xml: <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/NCT05976659</url>
    </required_header>
    <id_info>
      <org_study_id>30772</org_study_id>
      <nct_id>NCT05976659</nct_id>
    </id_info>
    <brief_title>Home-based Neuromodulation to Target Depression And Memory Symptoms in Older Adults</brief_title>
    <official_title>Targeting Depression And Memory Symptoms With Multi-Focal Circuit-Based Neuromodulation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hebrew SeniorLife</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Brain &amp; Behavior Research Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Hebrew SeniorLife</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This project aims to explore the feasibility and effects of a symptom-specific,&#xD;
        brain-circuit-based, home-based neuromodulation therapy for addressing mood and memory&#xD;
        symptoms in older adults with major depressive disorder (MDD) in the context of dementia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single arm pilot study to determine safety, feasibility, and preliminary efficacy&#xD;
        of a home-based brain stimulation intervention of transcranial direct current stimulation&#xD;
        (tDCS) targeting the prefrontal cortex, and transcranial alternating stimulation (tACS)&#xD;
        targeting the angular gyrus to improve depressive and episodic memory symptoms in individuals&#xD;
        with major depressive disorder (MDD) in the context of dementia. Participants will take part&#xD;
        in a series of pre-intervention assessments, the brain stimulation intervention consisting of&#xD;
        20 once-daily 20-minute stimulation sessions given over a period of 4 weeks, and a series of&#xD;
        post-intervention assessments (taken immediately after brain stimulation and 3 months after&#xD;
        stimulation).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 24, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Geriatric Depression Scale-15 Items (GDS-15)</measure>
      <time_frame>Change from Baseline GDS-15 total score at immediate post-intervention follow-up</time_frame>
      <description>This questionnaire is designed to evaluate depression in older adults.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rey Auditory Verbal Learning Test (RAVLT) Total Recall</measure>
      <time_frame>Change from Baseline RAVLT Total Recall total score at immediate post-intervention follow-up</time_frame>
      <description>This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cornell Scale for Depression in Dementia (CSDD)</measure>
      <time_frame>Change from Baseline CSDD total score at immediate post-intervention follow-up</time_frame>
      <description>This scale measures signs and symptoms of major depression in demented patients. Scores range from 0 to 38, with higher scores indicating higher level of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cornell Scale for Depression in Dementia (CSDD)</measure>
      <time_frame>Change from Baseline CSDD total score at 3 months follow-up</time_frame>
      <description>This scale measures signs and symptoms of major depression in demented patients. Scores range from 0 to 38, with higher scores indicating higher level of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Center for Epidemiological Studies-Depression (CES-D)</measure>
      <time_frame>Change from Baseline CES-D at immediate post-intervention follow-up</time_frame>
      <description>This scale is designed to measure self-reported symptoms associated with depression. Scores range from 0 to 60, with higher scores indicating worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Center for Epidemiological Studies-Depression (CES-D)</measure>
      <time_frame>Change from Baseline CES-D at 3 month follow-up</time_frame>
      <description>This scale is designed to measure self-reported symptoms associated with depression. Scores range from 0 to 60, with higher scores indicating worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores</measure>
      <time_frame>Change from Baseline MoCA at immediate post-intervention follow-up</time_frame>
      <description>A composite assessment tool that measures functionality of multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores</measure>
      <time_frame>Change from Baseline MoCA at 3 month follow up</time_frame>
      <description>A composite assessment tool that measures functionality of multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Digit Span (Forward and Backward)</measure>
      <time_frame>Change from Baseline Digit Span (Forward and Backward) at immediate post-intervention follow-up</time_frame>
      <description>A digit-span forward and backward task measures auditory registration, basic span of attention and working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to repeat the sequence of numbers verbally in the order that it was presented or in backwards order. The length of the sequence increases with each correct trial completion. The more numbers repeated the better a participants has done.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Digit Span (Forward and Backward)</measure>
      <time_frame>Change from Baseline Digit Span (Forward and Backward) at 3 month follow-up</time_frame>
      <description>A digit-span forward and backward task measures auditory registration, basic span of attention and working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to repeat the sequence of numbers verbally in the order that it was presented or in backwards order. The length of the sequence increases with each correct trial completion. The more numbers repeated the better a participants has done.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trail making test A and B</measure>
      <time_frame>Change from Baseline Trail making test A and B at immediate post-intervention follow-up</time_frame>
      <description>This test assess aspects of executive function such as psychomotor processing speed, visual search, cognitive flexibility, set shifting, multitasking.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trail making test A and B</measure>
      <time_frame>Change from Baseline Trail making test A and B at 3 month follow-up</time_frame>
      <description>This test assess aspects of executive function such as psychomotor processing speed, visual search, cognitive flexibility, set shifting, multitasking.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Category and Phonemic Fluency Test</measure>
      <time_frame>Change from Baseline in Category and Phonemic Fluency Test at immediate post-intervention follow-up</time_frame>
      <description>Test of semantic knowledge and word retrieval.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Category and Phonemic Fluency Test</measure>
      <time_frame>Change from Baseline in Category and Phonemic Fluency Test at 3 month follow-up</time_frame>
      <description>Test of semantic knowledge and word retrieval.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Activity Questionnaire (FAQ)</measure>
      <time_frame>Change from Baseline FAQ at immediate post-intervention follow-up</time_frame>
      <description>This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system:&#xD;
  Dependent = 3 Requires assistance = 2 Has difficulty but does by self = 1 Normal = 0 Never did [the activity] but could do now = 0 Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Activity Questionnaire (FAQ)</measure>
      <time_frame>Change from Baseline FAQ at 3 month follow-up</time_frame>
      <description>This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system:&#xD;
  Dependent = 3 Requires assistance = 2 Has difficulty but does by self = 1 Normal = 0 Never did [the activity] but could do now = 0 Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dementia Quality of Life Questionnaire (DEMQOL)</measure>
      <time_frame>Change from Baseline DEMQOL at immediate post-intervention follow-up</time_frame>
      <description>A questionnaire that is designed to assess the quality of life of a patient with dementia. Scores range from 28 to 112, where higher scores indicate better health-related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dementia Quality of Life Questionnaire (DEMQOL)</measure>
      <time_frame>Change from Baseline DEMQOL at 3 month follow-up</time_frame>
      <description>A questionnaire that is designed to assess the quality of life of a patient with dementia. Scores range from 28 to 112, where higher scores indicate better health-related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Altman Self-Rating Mania Scale (ASRM)</measure>
      <time_frame>Change from Baseline ASRM at immediate post-intervention follow-up</time_frame>
      <description>Screening instrument used to detect early warning signs of impending mania. Scores range from 0 to 20, with higher scores indicating worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Altman Self-Rating Mania Scale (ASRM)</measure>
      <time_frame>Change from Baseline ASRM at 3 month follow-up</time_frame>
      <description>Screening instrument used to detect early warning signs of impending mania. Scores range from 0 to 20, with higher scores indicating worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rey Auditory Verbal Learning Test (RAVLT) Total Recall</measure>
      <time_frame>Change from Baseline RAVLT Total Recall total score at 3 months follow-up</time_frame>
      <description>This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Geriatric Depression Scale-15 Items (GDS-15)</measure>
      <time_frame>Change from Baseline GDS-15 total score at 3 months follow-up</time_frame>
      <description>This questionnaire is designed to evaluate depression in older adults.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Major Depressive Disorder</condition>
    <condition>Alzheimer Disease</condition>
    <condition>Dementia</condition>
    <condition>Nervous System Diseases</condition>
    <condition>Memory Disorders</condition>
    <condition>Depressive Disorder</condition>
    <arm_group>
      <arm_group_label>tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will undergo 20 sessions of home-based tDCS over the prefrontal cortex and tACS over the left angular gyrus.These sessions will take place five times a week for four weeks, with one daily stimulation session of no more than 20 minutes. The participant's home will be the setting for the completion of the brain stimulation intervention, which will be delivered by trained caregivers/study companions/administrators.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)</intervention_name>
      <description>Transcranial electrical stimulation (tES), via direct and alternating current, will be administered to the participants in their home by trained caregivers/study companions administrators. All training and intervention sessions will take place in the participant's home.</description>
      <arm_group_label>tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD</arm_group_label>
      <other_name>Transcranial electrical stimulation (tES)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Participants (Ps)&#xD;
  &#xD;
            -  willing and capable to give informed consent for the participation in the study after&#xD;
               it has been thoroughly explained&#xD;
  &#xD;
            -  able and willing to comply with all study requirements&#xD;
  &#xD;
            -  an informed consent form was signed&#xD;
  &#xD;
            -  able to read, write, and communicate in English&#xD;
  &#xD;
            -  able to identify an eligible administrator to participate with them in the study&#xD;
               Caregiver/Administrators (As)&#xD;
  &#xD;
            -  at least 21 years of age&#xD;
  &#xD;
            -  able to read, write, and communicate in English&#xD;
  &#xD;
            -  self-reported computer proficiency and willingness to learn how to use tES as defined&#xD;
               by &quot;yes&quot; answers to the questions &quot;Do you feel comfortable using a computer?&quot; and &quot;Are&#xD;
               you willing to be the primary caregiver for a participant and learn how to administer&#xD;
               tES?&quot;&#xD;
  &#xD;
            -  stated availability during weekdays throughout the study period to administer tES to&#xD;
               the participant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  contraindications to tES, as recorded on a standardized screening questionnaire, which&#xD;
               include a reported seizure within the past two years, use of neuroactive drugs,&#xD;
               self-reported presence of specific implanted medical devices (e.g., deep brain&#xD;
               stimulator, medication infusion pump, cochlear implant, etc.)&#xD;
  &#xD;
            -  the presence of any active dermatological condition, such as eczema, on the scalp a&#xD;
               score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person&#xD;
               screen&#xD;
  &#xD;
            -  blindness or other disabilities that prevent task performance&#xD;
  &#xD;
            -  an inability to understand study procedures following review of the Informed Consent&#xD;
               form&#xD;
  &#xD;
            -  Understanding will be assessed by asking the participant to answer the following three&#xD;
               questions: 1) What is the purpose of this study? 2) What are the risks of study&#xD;
               involvement? 3) If you decide to participate, are you allowed to withdraw from the&#xD;
               study at any time? Answers will be recorded by study personnel on the &quot;Assessment of&#xD;
               Protocol Understanding&quot; form. Insufficient understanding will be defined by one or&#xD;
               more incorrect answers, as determined at the discretion of the investigator&#xD;
               Caregiver/Administrators (As)&#xD;
  &#xD;
            -  mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen&#xD;
  &#xD;
            -  insufficient understanding of study procedures following review of the Informed&#xD;
               Consent form Understanding will be assessed by asking the participant to answer the&#xD;
               following three questions: 1) What is the purpose of this study? 2) What are the risks&#xD;
               of study involvement? 3) If you decide to participate, are you allowed to withdraw&#xD;
               from the study at any time? Answers will be recorded by study personnel on the&#xD;
               &quot;Assessment of Protocol Understanding&quot; form. Insufficient understanding will be&#xD;
               defined by one or more incorrect answers, as determined at the discretion of the&#xD;
               investigator.&#xD;
  &#xD;
            -  poor eyesight, severe arthritis in the hands, pain, deformity or other condition that&#xD;
               interferes with successful administration of tES&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>HomeStim Study</last_name>
      <phone>617-971-5415</phone>
      <email>MoodMemStim@hsl.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hinda and Arthur Marcus Institute for Aging Research</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02131</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Davide Balos Cappon, MS; PhD</last_name>
      </contact>
      <contact_backup>
        <last_name>Rachel Fox, BS</last_name>
        <phone>617-971-5415</phone>
        <email>rachelfox@hsl.harvard.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Davide Balos Cappon, MS; PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Major Depressive Disorder</keyword>
    <keyword>Alzheimer's Disease</keyword>
    <keyword>Transcranial Direct Current Stimulation</keyword>
    <keyword>Transcranial Alternating Current Stimulation</keyword>
    <keyword>Memory</keyword>
    <keyword>Brain Stimulation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Nervous System Diseases</mesh_term>
      <mesh_term>Memory Disorders</mesh_term>
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Depressive Disorder, Major</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The prospective plan is to have data available in a data dementia-related data repository.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>The data will be available at the end of the study.</ipd_time_frame>
      <ipd_access_criteria>Depending on the repositories in which the data is held. However, use of the data will be restricted by permission and appropriate human subjects review of the prospective project.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05976659
  org study id: 30772
  nct id: NCT05976659
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This project aims to explore the feasibility and effects of a symptom-specific,
        brain-circuit-based, home-based neuromodulation therapy for addressing mood and memory
        symptoms in older adults with major depressive disorder (MDD) in the context of dementia.
  This is a single arm pilot study to determine safety, feasibility, and preliminary efficacy
        of a home-based brain stimulation intervention of transcranial direct current stimulation
        (tDCS) targeting the prefrontal cortex, and transcranial alternating stimulation (tACS)
        targeting the angular gyrus to improve depressive and episodic memory symptoms in individuals
        with major depressive disorder (MDD) in the context of dementia. Participants will take part
        in a series of pre-intervention assessments, the brain stimulation intervention consisting of
        20 once-daily 20-minute stimulation sessions given over a period of 4 weeks, and a series of
        post-intervention assessments (taken immediately after brain stimulation and 3 months after
        stimulation).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Geriatric Depression Scale-15 Items (GDS-15)
  time frame: Change from Baseline GDS-15 total score at immediate post-intervention follow-up
  description: This questionnaire is designed to evaluate depression in older adults.
  measure: Rey Auditory Verbal Learning Test (RAVLT) Total Recall
  time frame: Change from Baseline RAVLT Total Recall total score at immediate post-intervention follow-up
  description: This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time.
  measure: Cornell Scale for Depression in Dementia (CSDD)
  time frame: Change from Baseline CSDD total score at immediate post-intervention follow-up
  description: This scale measures signs and symptoms of major depression in demented patients. Scores range from 0 to 38, with higher scores indicating higher level of depression.
  measure: Cornell Scale for Depression in Dementia (CSDD)
  time frame: Change from Baseline CSDD total score at 3 months follow-up
  description: This scale measures signs and symptoms of major depression in demented patients. Scores range from 0 to 38, with higher scores indicating higher level of depression.
  measure: The Center for Epidemiological Studies-Depression (CES-D)
  time frame: Change from Baseline CES-D at immediate post-intervention follow-up
  description: This scale is designed to measure self-reported symptoms associated with depression. Scores range from 0 to 60, with higher scores indicating worse outcome.
  measure: The Center for Epidemiological Studies-Depression (CES-D)
  time frame: Change from Baseline CES-D at 3 month follow-up
  description: This scale is designed to measure self-reported symptoms associated with depression. Scores range from 0 to 60, with higher scores indicating worse outcome.
  measure: Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
  time frame: Change from Baseline MoCA at immediate post-intervention follow-up
  description: A composite assessment tool that measures functionality of multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating a better outcome.
  measure: Montreal Cognitive Assessment (MoCA) total score, memory and executive subscores
  time frame: Change from Baseline MoCA at 3 month follow up
  description: A composite assessment tool that measures functionality of multiple cognitive domains. Scores range from 0 to 30, with higher scores indicating a better outcome.
  measure: Digit Span (Forward and Backward)
  time frame: Change from Baseline Digit Span (Forward and Backward) at immediate post-intervention follow-up
  description: A digit-span forward and backward task measures auditory registration, basic span of attention and working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to repeat the sequence of numbers verbally in the order that it was presented or in backwards order. The length of the sequence increases with each correct trial completion. The more numbers repeated the better a participants has done.
  measure: Digit Span (Forward and Backward)
  time frame: Change from Baseline Digit Span (Forward and Backward) at 3 month follow-up
  description: A digit-span forward and backward task measures auditory registration, basic span of attention and working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to repeat the sequence of numbers verbally in the order that it was presented or in backwards order. The length of the sequence increases with each correct trial completion. The more numbers repeated the better a participants has done.
  measure: Trail making test A and B
  time frame: Change from Baseline Trail making test A and B at immediate post-intervention follow-up
  description: This test assess aspects of executive function such as psychomotor processing speed, visual search, cognitive flexibility, set shifting, multitasking.
  measure: Trail making test A and B
  time frame: Change from Baseline Trail making test A and B at 3 month follow-up
  description: This test assess aspects of executive function such as psychomotor processing speed, visual search, cognitive flexibility, set shifting, multitasking.
  measure: Category and Phonemic Fluency Test
  time frame: Change from Baseline in Category and Phonemic Fluency Test at immediate post-intervention follow-up
  description: Test of semantic knowledge and word retrieval.
  measure: Category and Phonemic Fluency Test
  time frame: Change from Baseline in Category and Phonemic Fluency Test at 3 month follow-up
  description: Test of semantic knowledge and word retrieval.
  measure: Functional Activity Questionnaire (FAQ)
  time frame: Change from Baseline FAQ at immediate post-intervention follow-up
  description: This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system:
  Dependent = 3 Requires assistance = 2 Has difficulty but does by self = 1 Normal = 0 Never did [the activity] but could do now = 0 Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.
  measure: Functional Activity Questionnaire (FAQ)
  time frame: Change from Baseline FAQ at 3 month follow-up
  description: This is a 10-item scale to measure functional status via independent activities of daily living. Each item is a functional activity, and the caregiver/informant rates the participant's ability using the following scoring system:
  Dependent = 3 Requires assistance = 2 Has difficulty but does by self = 1 Normal = 0 Never did [the activity] but could do now = 0 Never did and would have difficulty now = 1 The scores are summed (range 0-30). Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment. This test will be used to track functional status over the course of the intervention and follow-up.
  measure: Dementia Quality of Life Questionnaire (DEMQOL)
  time frame: Change from Baseline DEMQOL at immediate post-intervention follow-up
  description: A questionnaire that is designed to assess the quality of life of a patient with dementia. Scores range from 28 to 112, where higher scores indicate better health-related quality of life.
  measure: Dementia Quality of Life Questionnaire (DEMQOL)
  time frame: Change from Baseline DEMQOL at 3 month follow-up
  description: A questionnaire that is designed to assess the quality of life of a patient with dementia. Scores range from 28 to 112, where higher scores indicate better health-related quality of life.
  measure: Altman Self-Rating Mania Scale (ASRM)
  time frame: Change from Baseline ASRM at immediate post-intervention follow-up
  description: Screening instrument used to detect early warning signs of impending mania. Scores range from 0 to 20, with higher scores indicating worse outcome.
  measure: Altman Self-Rating Mania Scale (ASRM)
  time frame: Change from Baseline ASRM at 3 month follow-up
  description: Screening instrument used to detect early warning signs of impending mania. Scores range from 0 to 20, with higher scores indicating worse outcome.
  measure: Rey Auditory Verbal Learning Test (RAVLT) Total Recall
  time frame: Change from Baseline RAVLT Total Recall total score at 3 months follow-up
  description: This test is designed to evaluate verbal memory in those 16 years of age and older. It can be used to evaluate the nature and severity of memory dysfunction and to track changes in memory function over time.
  measure: Geriatric Depression Scale-15 Items (GDS-15)
  time frame: Change from Baseline GDS-15 total score at 3 months follow-up
  description: This questionnaire is designed to evaluate depression in older adults.
  arm group label: tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD
  arm group type: Experimental
  description: Participants will undergo 20 sessions of home-based tDCS over the prefrontal cortex and tACS over the left angular gyrus.These sessions will take place five times a week for four weeks, with one daily stimulation session of no more than 20 minutes. The participant's home will be the setting for the completion of the brain stimulation intervention, which will be delivered by trained caregivers/study companions/administrators.
  intervention type: Device
  intervention name: Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)
  description: Transcranial electrical stimulation (tES), via direct and alternating current, will be administered to the participants in their home by trained caregivers/study companions administrators. All training and intervention sessions will take place in the participant's home.
  arm group label: tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD
  other name: Transcranial electrical stimulation (tES)
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: No
  last name: HomeStim Study
  phone: 617-971-5415
  email: MoodMemStim@hsl.harvard.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Alzheimer Disease
  mesh term: Nervous System Diseases
  mesh term: Memory Disorders
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Depressive Disorder, Major
  sharing ipd: Yes
  ipd description: The prospective plan is to have data available in a data dementia-related data repository.
  ipd info type: Study Protocol
  ipd time frame: The data will be available at the end of the study.
  ipd access criteria: Depending on the repositories in which the data is held. However, use of the data will be restricted by permission and appropriate human subjects review of the prospective project.