<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/NCT03838211</url>
  </required_header>
  <id_info>
    <org_study_id>TrainStim3</org_study_id>
    <nct_id>NCT03838211</nct_id>
  </id_info>
  <brief_title>Brain Stimulation and Cognitive Training in Healthy Older Adults</brief_title>
  <acronym>TrainStim</acronym>
  <official_title>tDCS-accompanied Cognitive Training Effects in Healthy Older Adults - Randomised, Sham Controlled, Interventional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medicine Greifswald</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Medicine Greifswald</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>
      The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive&#xD;
      training of working memory leads to performance improvement in healthy older individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the present study is to assess behavioral (primary) and neural effects of a&#xD;
      multi-session cognitive training combined with transcranial direct current stimulation&#xD;
      (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various&#xD;
      cognitive functions by modulating cortical excitability in young adults, but its behavioral&#xD;
      impact and underlying mechanisms in aging still need to be elucidated. Healthy older adults&#xD;
      will participate in a three-week cognitive training with concurrent online tDCS application.&#xD;
      Cognitive performance (primary), as well as structural and functional imaging data will be&#xD;
      examined before, during and after the intervention. In order to draw conclusions about the&#xD;
      effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation&#xD;
      during training, will be assessed. Furthermore, to assess neural correlates of performance&#xD;
      improvement, functional and structural parameters will be measured with MRI before and after&#xD;
      training. Follow-up sessions to assess long-term effects are planned four weeks and six&#xD;
      months after the post assessment. The results of the study will offer valuable insights into&#xD;
      efficacy of combined tDCS and cognitive training, as compared to training alone, in older&#xD;
      adults. Moreover, improved understanding of tDCS effects on cognitive training performance&#xD;
      and underlying neural correlates may help to develop novel approaches for cognitive decline&#xD;
      in healthy and pathological aging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">March 25, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>
  </study_design_info>
  <primary_outcome>
    <measure>Working memory training performance (Letter Updating task)</measure>
    <time_frame>3 weeks</time_frame>
    <description>Performance in a memory training task (Letter updating) under anodal tDCS compared to sham condition;operationalized by working Memory Updating performance assessed with number of correctly recalled letter lists in the letter updating task, analyzed immediately after training period (anodal condition versus sham)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Working memory training performance (Markov task)</measure>
    <time_frame>3 weeks</time_frame>
    <description>Performance in second memory training task (Markov decision making) under anodal tDCS compared to sham condition, analyzed immediately after training period (anodal condition versus sham)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfer outcomes</measure>
    <time_frame>3 weeks</time_frame>
    <description>Performance in cognitive transfer tasks, comparing performance immediately before and after training period (anodal condition versus sham)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term outcomes</measure>
    <time_frame>4 weeks after training, 6 months after 4-week follow-up</time_frame>
    <description>Long-term performance in training and transfer tasks, comparing performance immediately before and after training period with performance at 4 weeks and 6-months after training period (anodal condition versus sham)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neural correlates</measure>
    <time_frame>3 weeks, 6 months</time_frame>
    <description>Structural and functional neural correlates of the intervention, as measured by structural, functional resting-state and diffusion weighted MRI, immediately before and after the intervention and 6 months after follow-up (anodal condition versus sham)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>stimulation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anodal tDCS + intensive cognitive Training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham tDCS + intensive cognitive Training</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anodal tDCS</intervention_name>
    <description>Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)</description>
    <arm_group_label>stimulation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive cognitive training</intervention_name>
    <description>Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions</description>
    <arm_group_label>sham group</arm_group_label>
    <arm_group_label>stimulation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older adults (65 - 80 years);&#xD;
&#xD;
          -  Right handedness;&#xD;
&#xD;
          -  Unobtrusive neuropsychological screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mild cognitive impairment (MCI) or dementia; other neurodegenerative neurological&#xD;
             disorders; epilepsy; previous stroke;&#xD;
&#xD;
          -  Severe and untreated medical conditions that precludes participation in the training,&#xD;
             as determined by responsible physician;&#xD;
&#xD;
          -  History of severe alcoholism or use of drugs;&#xD;
&#xD;
          -  Severe psychiatric disorders such as depression (if not in remission) or psychosis;&#xD;
&#xD;
          -  Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in&#xD;
             the body, disorders of thermoregulation, pregnant women)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Agnes Flöel, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>University Medicine Greifswald</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medicine Greifswald</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>memory</keyword>
  <keyword>brain stimulation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03838211/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03838211
org study id: TrainStim3
nct id: NCT03838211
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive
      training of working memory leads to performance improvement in healthy older individuals.
The goal of the present study is to assess behavioral (primary) and neural effects of a
      multi-session cognitive training combined with transcranial direct current stimulation
      (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various
      cognitive functions by modulating cortical excitability in young adults, but its behavioral
      impact and underlying mechanisms in aging still need to be elucidated. Healthy older adults
      will participate in a three-week cognitive training with concurrent online tDCS application.
      Cognitive performance (primary), as well as structural and functional imaging data will be
      examined before, during and after the intervention. In order to draw conclusions about the
      effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation
      during training, will be assessed. Furthermore, to assess neural correlates of performance
      improvement, functional and structural parameters will be measured with MRI before and after
      training. Follow-up sessions to assess long-term effects are planned four weeks and six
      months after the post assessment. The results of the study will offer valuable insights into
      efficacy of combined tDCS and cognitive training, as compared to training alone, in older
      adults. Moreover, improved understanding of tDCS effects on cognitive training performance
      and underlying neural correlates may help to develop novel approaches for cognitive decline
      in healthy and pathological aging.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Working memory training performance (Letter Updating task)
time frame: 3 weeks
description: Performance in a memory training task (Letter updating) under anodal tDCS compared to sham condition;operationalized by working Memory Updating performance assessed with number of correctly recalled letter lists in the letter updating task, analyzed immediately after training period (anodal condition versus sham)
measure: Working memory training performance (Markov task)
time frame: 3 weeks
description: Performance in second memory training task (Markov decision making) under anodal tDCS compared to sham condition, analyzed immediately after training period (anodal condition versus sham)
measure: Transfer outcomes
time frame: 3 weeks
description: Performance in cognitive transfer tasks, comparing performance immediately before and after training period (anodal condition versus sham)
measure: Long-term outcomes
time frame: 4 weeks after training, 6 months after 4-week follow-up
description: Long-term performance in training and transfer tasks, comparing performance immediately before and after training period with performance at 4 weeks and 6-months after training period (anodal condition versus sham)
measure: Neural correlates
time frame: 3 weeks, 6 months
description: Structural and functional neural correlates of the intervention, as measured by structural, functional resting-state and diffusion weighted MRI, immediately before and after the intervention and 6 months after follow-up (anodal condition versus sham)
arm group label: stimulation group
arm group type: Experimental
description: Anodal tDCS + intensive cognitive Training
arm group label: sham group
arm group type: Sham Comparator
description: Sham tDCS + intensive cognitive Training
intervention type: Device
intervention name: Anodal tDCS
description: Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)
arm group label: stimulation group
intervention type: Behavioral
intervention name: Intensive cognitive training
description: Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions
arm group label: sham group
arm group label: stimulation group
criteria: 
gender: All
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Agnes Flöel, Prof.
role: Study Director
affiliation: University Medicine Greifswald
facility: 
country: Germany
responsible party type: Sponsor
sharing ipd: No
provided document: 