<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03770182</url>
  </required_header>
  <id_info>
    <org_study_id>TPS-AD-Vienna</org_study_id>
    <nct_id>NCT03770182</nct_id>
  </id_info>
  <brief_title>Brain Stimulation for Neurological Patients</brief_title>
  <official_title>Brain Stimulation for Neurological Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Storz Medical AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Storz Medical AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective double-blind randomized placebo-controlled crossover clinical trial&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2017</start_date>
  <completion_date type="Actual">July 27, 2022</completion_date>
  <primary_completion_date type="Actual">July 27, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score</measure>
    <time_frame>month 3</time_frame>
    <description>CERAD stands for &quot;The Consortium to Establish a Registry for Alzheimer's Disease&quot;. The CERAD was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer's disease (Fillenbaum 2008). CERAD is a cognitive test battery which is normalized for age, gender and education (Morris 1988). The CERAD total score (Chandler 2005) is a good measure for Alzheimer's Disease (Ehrensperger 2010, Rossetti 2010, Seo 2010, Hallikainen 2013).&#xD;
The CERAD total score is a scale from 0 to 100 with 100 meaning &quot;normal cognitive ability&quot; and 0 meaning &quot;severe cognitive impairment&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alzheimer's Disease Assessment Scale (ADAS)</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.&#xD;
The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means &quot;healthy&quot; and the highest score means &quot;severe impairment&quot;. The total score ADASUM is the sum of both subscales.&#xD;
Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alzheimer's Disease Assessment Scale (ADAS)</measure>
    <time_frame>month 1</time_frame>
    <description>Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.&#xD;
The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means &quot;healthy&quot; and the highest score means &quot;severe impairment&quot;. The total score ADASUM is the sum of both subscales.&#xD;
Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alzheimer's Disease Assessment Scale (ADAS)</measure>
    <time_frame>month 3</time_frame>
    <description>Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.&#xD;
The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means &quot;healthy&quot; and the highest score means &quot;severe impairment&quot;. The total score ADASUM is the sum of both subscales.&#xD;
Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological Test Battery Vienna (NTBV)</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test, which was created to detect Alzheimer's Disease (Lehrner 2007).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological Test Battery Vienna (NTBV)</measure>
    <time_frame>month 1</time_frame>
    <description>Cognitive test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological Test Battery Vienna (NTBV)</measure>
    <time_frame>month 3</time_frame>
    <description>Cognitive test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CERAD</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>Cognitive test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CERAD</measure>
    <time_frame>month 1</time_frame>
    <description>Cognitive test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CERAD</measure>
    <time_frame>month 3</time_frame>
    <description>Cognitive test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clock drawing test</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>The clock drawing test shows the visuoconstructive skills (Shulman 1986). The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clock drawing test</measure>
    <time_frame>month 1</time_frame>
    <description>Clock drawing test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clock drawing test</measure>
    <time_frame>month 3</time_frame>
    <description>Clock drawing test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forgetfulness assessment inventory (FAI)</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>FAI stands for &quot;Forgetfulness Assessment Inventory&quot;. The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.&#xD;
The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.&#xD;
The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forgetfulness assessment inventory (FAI)</measure>
    <time_frame>month 1</time_frame>
    <description>FAI stands for &quot;Forgetfulness Assessment Inventory&quot;. The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.&#xD;
The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.&#xD;
The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forgetfulness assessment inventory (FAI)</measure>
    <time_frame>month 3</time_frame>
    <description>FAI stands for &quot;Forgetfulness Assessment Inventory&quot;. The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.&#xD;
The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.&#xD;
The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instrumental Activities of Daily Living Scale (IADL) - Patient</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>IADL stands for &quot;Instrumental Activities of Daily Living&quot;. Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.&#xD;
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IADL- Patient</measure>
    <time_frame>month 1</time_frame>
    <description>IADL stands for &quot;Instrumental Activities of Daily Living&quot;. Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.&#xD;
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IADL- Patient</measure>
    <time_frame>month 3</time_frame>
    <description>IADL stands for &quot;Instrumental Activities of Daily Living&quot;. Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.&#xD;
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>BDI stands for the &quot;Beck Depression Inventory&quot;. The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>month 1</time_frame>
    <description>BDI stands for the &quot;Beck Depression Inventory&quot;. The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>month 3</time_frame>
    <description>BDI stands for the &quot;Beck Depression Inventory&quot;. The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosopagnosia index (PI20)</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>PI20 stands for the &quot;20-item prosopagnosia index&quot;. The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosopagnosia index (PI20)</measure>
    <time_frame>month 1</time_frame>
    <description>PI20 stands for the &quot;20-item prosopagnosia index&quot;. The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosopagnosia index (PI20)</measure>
    <time_frame>month 3</time_frame>
    <description>PI20 stands for the &quot;20-item prosopagnosia index&quot;. The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric Inventory (NPI) (Care Taker)</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>The NPI stands for &quot;Neuropsychiatric Inventory&quot;. It is a questionnaire for care taker.&#xD;
The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.&#xD;
The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors.&#xD;
The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric Inventory (NPI) (Care Taker)</measure>
    <time_frame>month 1</time_frame>
    <description>The NPI stands for &quot;Neuropsychiatric Inventory&quot;. It is a questionnaire for care taker.&#xD;
The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.&#xD;
The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors.&#xD;
The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric Inventory (NPI) (Care Taker)</measure>
    <time_frame>month 3</time_frame>
    <description>The NPI stands for &quot;Neuropsychiatric Inventory&quot;. It is a questionnaire for care taker.&#xD;
The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.&#xD;
The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors.&#xD;
The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IADL (Care Taker)</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>Questionnaire for care taker. IADL stands for &quot;Instrumental Activities of Daily Living&quot;. Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.&#xD;
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IADL (Care Taker)</measure>
    <time_frame>month 1</time_frame>
    <description>Questionnaire for care taker. IADL stands for &quot;Instrumental Activities of Daily Living&quot;. Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.&#xD;
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IADL (Care Taker)</measure>
    <time_frame>month 3</time_frame>
    <description>Questionnaire for care taker. IADL stands for &quot;Instrumental Activities of Daily Living&quot;. Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.&#xD;
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bayer Activities of Daily Living Scale (B-ADL)</measure>
    <time_frame>[ Time Frame: immediately post-treatment ]</time_frame>
    <description>The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bayer Activities of Daily Living Scale (B-ADL)</measure>
    <time_frame>[ Time Frame: month 1 ]</time_frame>
    <description>The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bayer Activities of Daily Living Scale (B-ADL)</measure>
    <time_frame>[ Time Frame: month 3 ]</time_frame>
    <description>The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale - short form (GDS-15)</measure>
    <time_frame>[ Time Frame: immediately post-treatment ]</time_frame>
    <description>The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale - short form (GDS-15)</measure>
    <time_frame>[ Time Frame: month 1 ]</time_frame>
    <description>The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale - short form (GDS-15)</measure>
    <time_frame>[ Time Frame: month 3 ]</time_frame>
    <description>The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leisure Behavior (FZV; German: Freizeitverhalten)</measure>
    <time_frame>[ Time Frame: immediately post-treatment ]</time_frame>
    <description>The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leisure Behavior (FZV; German: Freizeitverhalten)</measure>
    <time_frame>[ Time Frame: month 1 ]</time_frame>
    <description>The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leisure Behavior (FZV; German: Freizeitverhalten)</measure>
    <time_frame>[ Time Frame: month 3 ]</time_frame>
    <description>The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anatomical Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>3 Tesla Magnetic Resonance Imaging (MRI) for safety reasons: no bleeding or anatomical changes to the brain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional Magnetic Resonance Imaging (fMRI)</measure>
    <time_frame>immediately post-treatment</time_frame>
    <description>3 Tesla functional Magnetic Resonance Imaging (MRI) to analyze brain activation and connectivity after TPS. This will be done according to Sperling 2001.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NEUROLITH&#xD;
Cycle 1: Active treatment&#xD;
Cycle 2: Sham treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NEUROLITH&#xD;
Cycle 1: Sham treatment&#xD;
Cycle 2: Active treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NEUROLITH</intervention_name>
    <description>transcranial pulse stimulation (TPS)</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <other_name>transcranial pulse stimulation</other_name>
    <other_name>TPS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to&#xD;
             ICD-10 Criteria (F00))&#xD;
&#xD;
          -  At least 3 months of stable antidementive therapy or no antidementive therapy&#xD;
             necessary&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
          -  Monthly pregnancy test for women in childbearing years&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-compliance with the protocol&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Relevant intracerebral pathology unrelated to the Alzheimers's disease (e.g. Brain&#xD;
             tumor)&#xD;
&#xD;
          -  Hemophilia or other blood clotting disorders&#xD;
&#xD;
          -  Cortisone treatment within the last 6 weeks before first treatment&#xD;
&#xD;
          -  Thrombosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roland Beisteiner, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Chandler MJ, Lacritz LH, Hynan LS, Barnard HD, Allen G, Deschner M, Weiner MF, Cullum CM. A total score for the CERAD neuropsychological battery. Neurology. 2005 Jul 12;65(1):102-6. doi: 10.1212/01.wnl.0000167607.63000.38.</citation>
    <PMID>16009893</PMID>
  </reference>
  <reference>
    <citation>Fillenbaum GG, van Belle G, Morris JC, Mohs RC, Mirra SS, Davis PC, Tariot PN, Silverman JM, Clark CM, Welsh-Bohmer KA, Heyman A. Consortium to Establish a Registry for Alzheimer's Disease (CERAD): the first twenty years. Alzheimers Dement. 2008 Mar;4(2):96-109. doi: 10.1016/j.jalz.2007.08.005.</citation>
    <PMID>18631955</PMID>
  </reference>
  <reference>
    <citation>Hallikainen I, Hanninen T, Fraunberg M, Hongisto K, Valimaki T, Hiltunen A, Karppi P, Sivenius J, Soininen H, Koivisto AM; ALSOVA study group. Progression of Alzheimer's disease during a three-year follow-up using the CERAD-NB total score: Kuopio ALSOVA study. Int Psychogeriatr. 2013 Aug;25(8):1335-44. doi: 10.1017/S1041610213000653. Epub 2013 May 16.</citation>
    <PMID>23676340</PMID>
  </reference>
  <reference>
    <citation>Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.</citation>
    <PMID>6496779</PMID>
  </reference>
  <reference>
    <citation>Morris JC, Mohs RC, Rogers H, Fillenbaum G, Heyman A. Consortium to establish a registry for Alzheimer's disease (CERAD) clinical and neuropsychological assessment of Alzheimer's disease. Psychopharmacol Bull. 1988;24(4):641-52. No abstract available.</citation>
    <PMID>3249766</PMID>
  </reference>
  <reference>
    <citation>Ehrensperger MM, Berres M, Taylor KI, Monsch AU. Early detection of Alzheimer's disease with a total score of the German CERAD. J Int Neuropsychol Soc. 2010 Sep;16(5):910-20. doi: 10.1017/S1355617710000822. Epub 2010 Aug 4.</citation>
    <PMID>20682088</PMID>
  </reference>
  <reference>
    <citation>Rossetti HC, Munro Cullum C, Hynan LS, Lacritz LH. The CERAD Neuropsychologic Battery Total Score and the progression of Alzheimer disease. Alzheimer Dis Assoc Disord. 2010 Apr-Jun;24(2):138-42. doi: 10.1097/WAD.0b013e3181b76415.</citation>
    <PMID>20505431</PMID>
  </reference>
  <reference>
    <citation>Seo EH, Lee DY, Lee JH, Choo IH, Kim JW, Kim SG, Park SY, Shin JH, Do YJ, Yoon JC, Jhoo JH, Kim KW, Woo JI. Total scores of the CERAD neuropsychological assessment battery: validation for mild cognitive impairment and dementia patients with diverse etiologies. Am J Geriatr Psychiatry. 2010 Sep;18(9):801-9. doi: 10.1097/JGP.0b013e3181cab764.</citation>
    <PMID>20220577</PMID>
  </reference>
  <reference>
    <citation>Irizarry MC, Webb DJ, Bains C, Barrett SJ, Lai RY, Laroche JP, Hosford D, Maher-Edwards G, Weil JG. Predictors of placebo group decline in the Alzheimer's disease Assessment Scale-cognitive subscale (ADAS-Cog) in 24 week clinical trials of Alzheimer's disease. J Alzheimers Dis. 2008 Jul;14(3):301-11. doi: 10.3233/jad-2008-14304.</citation>
    <PMID>18599956</PMID>
  </reference>
  <reference>
    <citation>Robert P, Ferris S, Gauthier S, Ihl R, Winblad B, Tennigkeit F. Review of Alzheimer's disease scales: is there a need for a new multi-domain scale for therapy evaluation in medical practice? Alzheimers Res Ther. 2010 Aug 26;2(4):24. doi: 10.1186/alzrt48.</citation>
    <PMID>20796301</PMID>
  </reference>
  <reference>
    <citation>Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. &amp; Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.</citation>
  </reference>
  <reference>
    <citation>Shulman, K. I.; Shedletsky, R. &amp; Silver, I. L.The challenge of time: Clock-drawing and cognitive function in the elderly. International journal of geriatric psychiatry, Wiley Online Library 1: 135-140, 1986.</citation>
  </reference>
  <reference>
    <citation>Kogler, B. Subjective Memory Complaint in Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease. Vienna: University of Vienna, 2013</citation>
  </reference>
  <reference>
    <citation>Lehrner J, Moser D, Klug S, Gleiss A, Auff E, Dal-Bianco P, Pusswald G. Subjective memory complaints, depressive symptoms and cognition in patients attending a memory outpatient clinic. Int Psychogeriatr. 2014 Mar;26(3):463-73. doi: 10.1017/S1041610213002263. Epub 2013 Dec 5.</citation>
    <PMID>24308705</PMID>
  </reference>
  <reference>
    <citation>Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.</citation>
    <PMID>5349366</PMID>
  </reference>
  <reference>
    <citation>BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.</citation>
    <PMID>13688369</PMID>
  </reference>
  <reference>
    <citation>Shah P, Gaule A, Sowden S, Bird G, Cook R. The 20-item prosopagnosia index (PI20): a self-report instrument for identifying developmental prosopagnosia. R Soc Open Sci. 2015 Jun 24;2(6):140343. doi: 10.1098/rsos.140343. eCollection 2015 Jun.</citation>
    <PMID>26543567</PMID>
  </reference>
  <reference>
    <citation>Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.</citation>
    <PMID>9153155</PMID>
  </reference>
  <reference>
    <citation>Sperling RA, Bates JF, Cocchiarella AJ, Schacter DL, Rosen BR, Albert MS. Encoding novel face-name associations: a functional MRI study. Hum Brain Mapp. 2001 Nov;14(3):129-39. doi: 10.1002/hbm.1047.</citation>
    <PMID>11559958</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770182
org study id: TPS-AD-Vienna
nct id: NCT03770182
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective double-blind randomized placebo-controlled crossover clinical trial
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score
time frame: month 3
description: CERAD stands for "The Consortium to Establish a Registry for Alzheimer's Disease". The CERAD was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer's disease (Fillenbaum 2008). CERAD is a cognitive test battery which is normalized for age, gender and education (Morris 1988). The CERAD total score (Chandler 2005) is a good measure for Alzheimer's Disease (Ehrensperger 2010, Rossetti 2010, Seo 2010, Hallikainen 2013).
The CERAD total score is a scale from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".
measure: Alzheimer's Disease Assessment Scale (ADAS)
time frame: immediately post-treatment
description: Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.
The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.
Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.
measure: Alzheimer's Disease Assessment Scale (ADAS)
time frame: month 1
description: Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.
The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.
Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.
measure: Alzheimer's Disease Assessment Scale (ADAS)
time frame: month 3
description: Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies.
The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales.
Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.
measure: Neuropsychological Test Battery Vienna (NTBV)
time frame: immediately post-treatment
description: The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test, which was created to detect Alzheimer's Disease (Lehrner 2007).
measure: Neuropsychological Test Battery Vienna (NTBV)
time frame: month 1
description: Cognitive test
measure: Neuropsychological Test Battery Vienna (NTBV)
time frame: month 3
description: Cognitive test
measure: CERAD
time frame: immediately post-treatment
description: Cognitive test
measure: CERAD
time frame: month 1
description: Cognitive test
measure: CERAD
time frame: month 3
description: Cognitive test
measure: Clock drawing test
time frame: immediately post-treatment
description: The clock drawing test shows the visuoconstructive skills (Shulman 1986). The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best).
measure: Clock drawing test
time frame: month 1
description: Clock drawing test
measure: Clock drawing test
time frame: month 3
description: Clock drawing test
measure: Forgetfulness assessment inventory (FAI)
time frame: immediately post-treatment
description: FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.
The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.
The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.
measure: Forgetfulness assessment inventory (FAI)
time frame: month 1
description: FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.
The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.
The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.
measure: Forgetfulness assessment inventory (FAI)
time frame: month 3
description: FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale.
The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.
The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.
measure: Instrumental Activities of Daily Living Scale (IADL) - Patient
time frame: immediately post-treatment
description: IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
measure: IADL- Patient
time frame: month 1
description: IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
measure: IADL- Patient
time frame: month 3
description: IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
measure: Beck Depression Inventory (BDI)
time frame: immediately post-treatment
description: BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
measure: Beck Depression Inventory (BDI)
time frame: month 1
description: BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
measure: Beck Depression Inventory (BDI)
time frame: month 3
description: BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
measure: Prosopagnosia index (PI20)
time frame: immediately post-treatment
description: PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.
measure: Prosopagnosia index (PI20)
time frame: month 1
description: PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.
measure: Prosopagnosia index (PI20)
time frame: month 3
description: PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.
measure: Neuropsychiatric Inventory (NPI) (Care Taker)
time frame: immediately post-treatment
description: The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.
The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.
The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors.
The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.
measure: Neuropsychiatric Inventory (NPI) (Care Taker)
time frame: month 1
description: The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.
The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.
The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors.
The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.
measure: Neuropsychiatric Inventory (NPI) (Care Taker)
time frame: month 3
description: The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker.
The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI.
The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors.
The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.
measure: IADL (Care Taker)
time frame: immediately post-treatment
description: Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
measure: IADL (Care Taker)
time frame: month 1
description: Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
measure: IADL (Care Taker)
time frame: month 3
description: Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances.
The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
measure: Bayer Activities of Daily Living Scale (B-ADL)
time frame: [ Time Frame: immediately post-treatment ]
description: The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
measure: Bayer Activities of Daily Living Scale (B-ADL)
time frame: [ Time Frame: month 1 ]
description: The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
measure: Bayer Activities of Daily Living Scale (B-ADL)
time frame: [ Time Frame: month 3 ]
description: The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
measure: Geriatric Depression Scale - short form (GDS-15)
time frame: [ Time Frame: immediately post-treatment ]
description: The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
measure: Geriatric Depression Scale - short form (GDS-15)
time frame: [ Time Frame: month 1 ]
description: The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
measure: Geriatric Depression Scale - short form (GDS-15)
time frame: [ Time Frame: month 3 ]
description: The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
measure: Leisure Behavior (FZV; German: Freizeitverhalten)
time frame: [ Time Frame: immediately post-treatment ]
description: The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
measure: Leisure Behavior (FZV; German: Freizeitverhalten)
time frame: [ Time Frame: month 1 ]
description: The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
measure: Leisure Behavior (FZV; German: Freizeitverhalten)
time frame: [ Time Frame: month 3 ]
description: The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
measure: anatomical Magnetic Resonance Imaging (MRI)
time frame: immediately post-treatment
description: 3 Tesla Magnetic Resonance Imaging (MRI) for safety reasons: no bleeding or anatomical changes to the brain.
measure: functional Magnetic Resonance Imaging (fMRI)
time frame: immediately post-treatment
description: 3 Tesla functional Magnetic Resonance Imaging (MRI) to analyze brain activation and connectivity after TPS. This will be done according to Sperling 2001.
arm group label: Group A
arm group type: Experimental
description: NEUROLITH
Cycle 1: Active treatment
Cycle 2: Sham treatment
arm group label: Group B
arm group type: Experimental
description: NEUROLITH
Cycle 1: Sham treatment
Cycle 2: Active treatment
intervention type: Device
intervention name: NEUROLITH
description: transcranial pulse stimulation (TPS)
arm group label: Group A
arm group label: Group B
other name: transcranial pulse stimulation
other name: TPS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roland Beisteiner, Prof.
role: Principal Investigator
affiliation: Medical University of Vienna
facility: 
country: Austria
citation: Chandler MJ, Lacritz LH, Hynan LS, Barnard HD, Allen G, Deschner M, Weiner MF, Cullum CM. A total score for the CERAD neuropsychological battery. Neurology. 2005 Jul 12;65(1):102-6. doi: 10.1212/01.wnl.0000167607.63000.38.
PMID: 16009893
citation: Fillenbaum GG, van Belle G, Morris JC, Mohs RC, Mirra SS, Davis PC, Tariot PN, Silverman JM, Clark CM, Welsh-Bohmer KA, Heyman A. Consortium to Establish a Registry for Alzheimer's Disease (CERAD): the first twenty years. Alzheimers Dement. 2008 Mar;4(2):96-109. doi: 10.1016/j.jalz.2007.08.005.
PMID: 18631955
citation: Hallikainen I, Hanninen T, Fraunberg M, Hongisto K, Valimaki T, Hiltunen A, Karppi P, Sivenius J, Soininen H, Koivisto AM; ALSOVA study group. Progression of Alzheimer's disease during a three-year follow-up using the CERAD-NB total score: Kuopio ALSOVA study. Int Psychogeriatr. 2013 Aug;25(8):1335-44. doi: 10.1017/S1041610213000653. Epub 2013 May 16.
PMID: 23676340
citation: Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
PMID: 6496779
citation: Morris JC, Mohs RC, Rogers H, Fillenbaum G, Heyman A. Consortium to establish a registry for Alzheimer's disease (CERAD) clinical and neuropsychological assessment of Alzheimer's disease. Psychopharmacol Bull. 1988;24(4):641-52. No abstract available.
PMID: 3249766
citation: Ehrensperger MM, Berres M, Taylor KI, Monsch AU. Early detection of Alzheimer's disease with a total score of the German CERAD. J Int Neuropsychol Soc. 2010 Sep;16(5):910-20. doi: 10.1017/S1355617710000822. Epub 2010 Aug 4.
PMID: 20682088
citation: Rossetti HC, Munro Cullum C, Hynan LS, Lacritz LH. The CERAD Neuropsychologic Battery Total Score and the progression of Alzheimer disease. Alzheimer Dis Assoc Disord. 2010 Apr-Jun;24(2):138-42. doi: 10.1097/WAD.0b013e3181b76415.
PMID: 20505431
citation: Seo EH, Lee DY, Lee JH, Choo IH, Kim JW, Kim SG, Park SY, Shin JH, Do YJ, Yoon JC, Jhoo JH, Kim KW, Woo JI. Total scores of the CERAD neuropsychological assessment battery: validation for mild cognitive impairment and dementia patients with diverse etiologies. Am J Geriatr Psychiatry. 2010 Sep;18(9):801-9. doi: 10.1097/JGP.0b013e3181cab764.
PMID: 20220577
citation: Irizarry MC, Webb DJ, Bains C, Barrett SJ, Lai RY, Laroche JP, Hosford D, Maher-Edwards G, Weil JG. Predictors of placebo group decline in the Alzheimer's disease Assessment Scale-cognitive subscale (ADAS-Cog) in 24 week clinical trials of Alzheimer's disease. J Alzheimers Dis. 2008 Jul;14(3):301-11. doi: 10.3233/jad-2008-14304.
PMID: 18599956
citation: Robert P, Ferris S, Gauthier S, Ihl R, Winblad B, Tennigkeit F. Review of Alzheimer's disease scales: is there a need for a new multi-domain scale for therapy evaluation in medical practice? Alzheimers Res Ther. 2010 Aug 26;2(4):24. doi: 10.1186/alzrt48.
PMID: 20796301
citation: Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.
citation: Shulman, K. I.; Shedletsky, R. & Silver, I. L.The challenge of time: Clock-drawing and cognitive function in the elderly. International journal of geriatric psychiatry, Wiley Online Library 1: 135-140, 1986.
citation: Kogler, B. Subjective Memory Complaint in Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease. Vienna: University of Vienna, 2013
citation: Lehrner J, Moser D, Klug S, Gleiss A, Auff E, Dal-Bianco P, Pusswald G. Subjective memory complaints, depressive symptoms and cognition in patients attending a memory outpatient clinic. Int Psychogeriatr. 2014 Mar;26(3):463-73. doi: 10.1017/S1041610213002263. Epub 2013 Dec 5.
PMID: 24308705
citation: Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
PMID: 5349366
citation: BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PMID: 13688369
citation: Shah P, Gaule A, Sowden S, Bird G, Cook R. The 20-item prosopagnosia index (PI20): a self-report instrument for identifying developmental prosopagnosia. R Soc Open Sci. 2015 Jun 24;2(6):140343. doi: 10.1098/rsos.140343. eCollection 2015 Jun.
PMID: 26543567
citation: Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
PMID: 9153155
citation: Sperling RA, Bates JF, Cocchiarella AJ, Schacter DL, Rosen BR, Albert MS. Encoding novel face-name associations: a functional MRI study. Hum Brain Mapp. 2001 Nov;14(3):129-39. doi: 10.1002/hbm.1047.
PMID: 11559958
responsible party type: Sponsor
mesh term: Alzheimer Disease