<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/NCT03236454</url>
  </required_header>
  <id_info>
    <org_study_id>SCDStim-1</org_study_id>
    <nct_id>NCT03236454</nct_id>
  </id_info>
  <brief_title>tDCS-enhanced Working Memory Training in Subjective Cognitive Decline</brief_title>
  <official_title>Effects and Mechanisms of Cognitive Control Training Combined With Transcranial Direct Current Stimulation (tDCS) in Subjective Cognitive Decline.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</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 2-armed randomized, sham-controlled, single-blind study aims at providing evidence for&#xD;
      the efficacy of a transcranial direct current stimulation (tDCS)-enhanced cognitive control&#xD;
      training (PASAT) in participants with subjective cognitive decline (SCD). Overall, the study&#xD;
      will include 30 participants. Each participant will take part in a four weeks training (12&#xD;
      sessions); 50% of the participants will receive 2mA anodal tDCS for 20 minutes applied to the&#xD;
      left dorsolateral prefrontal cortex (dlPFC), the other half will receive sham stimulation.&#xD;
      Event-related potentials (ERPs) evoked by the feedback on the correctness of the response at&#xD;
      baseline and after training will be measured with EEG as neurophysiological signatures of&#xD;
      cognitive control. Near and far transfer will be assessed by a verbal 2-back task and the&#xD;
      Trail Making Test A and B. The amount of worrying regarding the memory impairment will be&#xD;
      quantified by means of a 10 point Likert-Scale. Together with changes of PASAT performance&#xD;
      these measures will be obtained before and after the tDCS-enhanced training. Follow-up&#xD;
      assessments 3, 12 and 24 months after training will investigate the stability of training&#xD;
      effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 11, 2017</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Sham Stimulation: Ramping up over 50 seconds at the beginning and an equal amount of time for tapering off at the end</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in amount of worrying regarding the memory impairment</measure>
    <time_frame>4 weeks</time_frame>
    <description>The amount of worrying regarding the memory impairment will be quantified by means of a 10-point Likert-Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Group comparison (active vs. sham tDCS) regarding the change in amount of correct answers in the PASAT task from baseline to end of training period.</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group comparison (active vs. sham tDCS) regarding the change in amount of correct answers in the verbal 2-back task (pre-session outcomes compared with post-session and follow-up outcomes).</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group comparison (active vs. sham tDCS) regarding changes in Trail Making Task A and B outcomes (pre-session outcomes compared with post-session and follow-up outcomes).</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group comparison (active vs. sham tDCS) regarding changes in Satisfaction With Life Scale outcomes (pre-session outcomes compared with post-session and follow-up outcomes).</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Group comparison (active vs. sham tDCS) regarding changes in the Neuropsychological Test Battery CERAD-Plus (pre-session outcomes compared with follow-up outcomes).</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Subjective Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>anodal tDCS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DC-Stimulator MC, NeuroConn: 20 minutes of 2 mA anodal stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>DC-Stimulator MC, NeuroConn: 20 minutes of sham stimulation; Ramping up over 50 seconds at the beginning and an equal amount of time for tapering off at the end;</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DC-Stimulator MC, NeuroConn</intervention_name>
    <description>20 minutes of 2 mA anodal stimulation; Electrode placement: left dorsolateral prefrontal cortex (F3, EEG 10/20 system), return electrode at the right upper arm.</description>
    <arm_group_label>anodal tDCS</arm_group_label>
    <arm_group_label>sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Men and women, aged 60 years and above Native German speaker Subjective feeling of&#xD;
        worsening cognitive abilities, including memory Present concerns regarding the subjective&#xD;
        memory decline Right handedness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Present objective cognitive impairment (Mini-Mental State Examination &lt; 24)&#xD;
&#xD;
          -  Current depression or depressive episode (Geriatric Depression Scale &gt; 5)&#xD;
&#xD;
          -  Current substance abuse&#xD;
&#xD;
          -  Presence of other psychiatric disorders (MINI International Neuropsychiatric&#xD;
             Interview)&#xD;
&#xD;
          -  History of epilepsy&#xD;
&#xD;
          -  Presence of other neurological disorders&#xD;
&#xD;
          -  Absence of independent living skills (Instrumental Activities Of Daily Living, IADL)&#xD;
             Scale)&#xD;
&#xD;
          -  Metallic implants near the electrodes (i.e. pacemakers)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Plewnia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tübingen, Department of Psychiatry and Psychotherapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Tübingen, Department of Psychiatry and Psychotherapy</name>
      <address>
        <city>Tübingen</city>
        <zip>72074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>January 9, 2020</last_update_submitted>
  <last_update_submitted_qc>January 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Tuebingen</investigator_affiliation>
    <investigator_full_name>Christian Plewnia, MD</investigator_full_name>
    <investigator_title>Apl. Prof.</investigator_title>
  </responsible_party>
  <keyword>brain stimulation</keyword>
  <keyword>cognitive training</keyword>
  <keyword>cognition</keyword>
  <keyword>treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03236454
org study id: SCDStim-1
nct id: NCT03236454
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This 2-armed randomized, sham-controlled, single-blind study aims at providing evidence for
      the efficacy of a transcranial direct current stimulation (tDCS)-enhanced cognitive control
      training (PASAT) in participants with subjective cognitive decline (SCD). Overall, the study
      will include 30 participants. Each participant will take part in a four weeks training (12
      sessions); 50% of the participants will receive 2mA anodal tDCS for 20 minutes applied to the
      left dorsolateral prefrontal cortex (dlPFC), the other half will receive sham stimulation.
      Event-related potentials (ERPs) evoked by the feedback on the correctness of the response at
      baseline and after training will be measured with EEG as neurophysiological signatures of
      cognitive control. Near and far transfer will be assessed by a verbal 2-back task and the
      Trail Making Test A and B. The amount of worrying regarding the memory impairment will be
      quantified by means of a 10 point Likert-Scale. Together with changes of PASAT performance
      these measures will be obtained before and after the tDCS-enhanced training. Follow-up
      assessments 3, 12 and 24 months after training will investigate the stability of training
      effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Sham Stimulation: Ramping up over 50 seconds at the beginning and an equal amount of time for tapering off at the end
measure: Change in amount of worrying regarding the memory impairment
time frame: 4 weeks
description: The amount of worrying regarding the memory impairment will be quantified by means of a 10-point Likert-Scale
measure: Group comparison (active vs. sham tDCS) regarding the change in amount of correct answers in the PASAT task from baseline to end of training period.
time frame: 4 weeks
measure: Group comparison (active vs. sham tDCS) regarding the change in amount of correct answers in the verbal 2-back task (pre-session outcomes compared with post-session and follow-up outcomes).
time frame: 2 years
measure: Group comparison (active vs. sham tDCS) regarding changes in Trail Making Task A and B outcomes (pre-session outcomes compared with post-session and follow-up outcomes).
time frame: 2 years
measure: Group comparison (active vs. sham tDCS) regarding changes in Satisfaction With Life Scale outcomes (pre-session outcomes compared with post-session and follow-up outcomes).
time frame: 2 years
measure: Group comparison (active vs. sham tDCS) regarding changes in the Neuropsychological Test Battery CERAD-Plus (pre-session outcomes compared with follow-up outcomes).
time frame: 2 years
arm group label: anodal tDCS
arm group type: Active Comparator
description: DC-Stimulator MC, NeuroConn: 20 minutes of 2 mA anodal stimulation
arm group label: sham tDCS
arm group type: Sham Comparator
description: DC-Stimulator MC, NeuroConn: 20 minutes of sham stimulation; Ramping up over 50 seconds at the beginning and an equal amount of time for tapering off at the end;
intervention type: Device
intervention name: DC-Stimulator MC, NeuroConn
description: 20 minutes of 2 mA anodal stimulation; Electrode placement: left dorsolateral prefrontal cortex (F3, EEG 10/20 system), return electrode at the right upper arm.
arm group label: anodal tDCS
arm group label: sham tDCS
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christian Plewnia, MD
role: Principal Investigator
affiliation: University of Tübingen, Department of Psychiatry and Psychotherapy
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Tuebingen
investigator full name: Christian Plewnia, MD
investigator title: Apl. Prof.
mesh term: Cognitive Dysfunction
sharing ipd: Undecided