<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/NCT02997007</url>
  </required_header>
  <id_info>
    <org_study_id>NL57751.068.16</org_study_id>
    <nct_id>NCT02997007</nct_id>
  </id_info>
  <brief_title>Neural Correlates of Repeated tDCS</brief_title>
  <official_title>Investigating the Neural Correlates of Repeated tDCS in MCI and Healthy Ageing With fMRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Healthy ageing and pathological ageing in the context of a neurodegenerative disease are both&#xD;
      associated with changes in brain network integrity. Episodic memory is especially affected in&#xD;
      Alzheimer's disease, but is also decreased in healthy ageing. Consequently, the&#xD;
      memory-relevant brain networks are especially altered. Transcranial direct current&#xD;
      stimulation (tDCS) has previously been implemented in different clinical- and non-clinical&#xD;
      settings and has shown to beneficially influence network connectivity. The neural correlates&#xD;
      of single-session tDCS have been investigated, however, the neural effects of repeated tDCS&#xD;
      remain unknown. Furthermore, knowledge about the (long-term) neural mechanisms of repeated&#xD;
      tDCS can give valuable insights and possibly pave the ground for exploring tDCS as a&#xD;
      treatment option in future studies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>neural changes after multi-session tDCS</measure>
    <time_frame>5-12 days</time_frame>
    <description>fMRI-BOLD response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>network changes after multi-session tDCS</measure>
    <time_frame>5-12 days</time_frame>
    <description>functional connectivity between network hubs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Task performance changes after multi-session tDCS</measure>
    <time_frame>5-12 days</time_frame>
    <description>BPS-score</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>MCI-active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive verum tDCS over the angular gyrus on five consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MCI-sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will receive sham tDCS over the angular gyrus on five consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Old-active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive verum tDCS over the angular gyrus on five consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy old-sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will receive sham tDCS over the angular gyrus on five consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>active tDCS</intervention_name>
    <description>Participants will receive active tDCS over the angular gyrus on five consecutive days</description>
    <arm_group_label>Healthy Old-active</arm_group_label>
    <arm_group_label>MCI-active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham tDCS</intervention_name>
    <description>Participants will receive sham tDCS over the angular gyrus on five consecutive days</description>
    <arm_group_label>Healthy old-sham</arm_group_label>
    <arm_group_label>MCI-sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  Diagnosis of MCI based on the latest research criteria (clinical assessment at the&#xD;
             memory clinic (prof. Frans RJ Verhey): presence of at least a memory impairment,&#xD;
             memory complaints expressed by the patient or informant, no problems in daily life&#xD;
             functioning, no dementia and presence of biomarkers (Albert et al., 2011)&#xD;
&#xD;
          -  Clinical Dementia Rating score of 0.5 (CDR distinguishes a stage of questionable&#xD;
             dementia (CDR 0.5) from people termed healthy (CDR 0) and those with mild dementia&#xD;
             (CDR 1)&#xD;
&#xD;
          -  Mini-Mental State Examination (MMSE) 23 and being mentally competent (in general,&#xD;
             individuals with a MMSE 18 are considered mentally competent)&#xD;
&#xD;
          -  Age: between 60 and 85 years old&#xD;
&#xD;
          -  50% female&#xD;
&#xD;
          -  Right-handedness&#xD;
&#xD;
          -  Average level of education (CBS level 3-4-5-6)&#xD;
&#xD;
        Healthy controls&#xD;
&#xD;
          -  Average neuropsychological test results, in accordance with normative data, corrected&#xD;
             for age, education and gender&#xD;
&#xD;
          -  No substantial memory complaints (according to the participant)&#xD;
&#xD;
          -  Age: between 60 and 85 years old&#xD;
&#xD;
          -  50% female&#xD;
&#xD;
          -  Right-handedness&#xD;
&#xD;
          -  Average level of education (CBS level 3-4-5-6)&#xD;
&#xD;
          -  Normal or corrected to normal vision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychoactive medication use&#xD;
&#xD;
          -  Abuse of alcohol and drugs&#xD;
&#xD;
          -  Cognitive impairment due to alcohol/drug abuse or abuse of other substances&#xD;
&#xD;
          -  Past or present psychiatric or neurological disorders (major depression,&#xD;
             schizophrenia, bipolar disorder, psychotic disorder (or treatment for it), epilepsy,&#xD;
             stroke, Parkinson's disease, multiple sclerosis, brain surgery, brain trauma,&#xD;
             electroshock therapy, kidney dialysis, Menière's disease, brain infections)&#xD;
&#xD;
          -  Major vascular disorders (e.g. stroke)&#xD;
&#xD;
          -  Heart diseases or pacemakers&#xD;
&#xD;
          -  Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants,&#xD;
             claustrophobia, body tattoos)&#xD;
&#xD;
          -  Large scars or fresh wounds on the scalp&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heidi IL Jacobs, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Frans RJ Verhey, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Maastricht University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lisa Müller-Ehrenberg, MSc</last_name>
    <phone>0031433881025</phone>
    <email>l.muller-ehrenberg@maastrichtuniversity.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Heidi IL Jacobs, PhD</last_name>
    <phone>0031433884090</phone>
    <email>h.jacobs@maastrichtuniversity.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maastricht University</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6221ET</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lisa Müller-Ehrenberg, MSc</last_name>
      <phone>0031433881025</phone>
      <email>l.muller-ehrenberg@maastrichtuniversity.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>March 22, 2018</last_update_submitted>
  <last_update_submitted_qc>March 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tDCS</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <keyword>fMRI</keyword>
  <keyword>Healthy ageing</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/NCT02997007
org study id: NL57751.068.16
nct id: NCT02997007
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Healthy ageing and pathological ageing in the context of a neurodegenerative disease are both
      associated with changes in brain network integrity. Episodic memory is especially affected in
      Alzheimer's disease, but is also decreased in healthy ageing. Consequently, the
      memory-relevant brain networks are especially altered. Transcranial direct current
      stimulation (tDCS) has previously been implemented in different clinical- and non-clinical
      settings and has shown to beneficially influence network connectivity. The neural correlates
      of single-session tDCS have been investigated, however, the neural effects of repeated tDCS
      remain unknown. Furthermore, knowledge about the (long-term) neural mechanisms of repeated
      tDCS can give valuable insights and possibly pave the ground for exploring tDCS as a
      treatment option in future studies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: neural changes after multi-session tDCS
time frame: 5-12 days
description: fMRI-BOLD response
measure: network changes after multi-session tDCS
time frame: 5-12 days
description: functional connectivity between network hubs
measure: Task performance changes after multi-session tDCS
time frame: 5-12 days
description: BPS-score
arm group label: MCI-active
arm group type: Experimental
description: Patients will receive verum tDCS over the angular gyrus on five consecutive days.
arm group label: MCI-sham
arm group type: Sham Comparator
description: Patients will receive sham tDCS over the angular gyrus on five consecutive days.
arm group label: Healthy Old-active
arm group type: Experimental
description: Participants will receive verum tDCS over the angular gyrus on five consecutive days.
arm group label: Healthy old-sham
arm group type: Sham Comparator
description: Participants will receive sham tDCS over the angular gyrus on five consecutive days.
intervention type: Device
intervention name: active tDCS
description: Participants will receive active tDCS over the angular gyrus on five consecutive days
arm group label: Healthy Old-active
arm group label: MCI-active
intervention type: Device
intervention name: sham tDCS
description: Participants will receive sham tDCS over the angular gyrus on five consecutive days
arm group label: Healthy old-sham
arm group label: MCI-sham
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Heidi IL Jacobs, PhD
role: Principal Investigator
affiliation: Maastricht University
last name: Frans RJ Verhey, Professor
role: Study Chair
affiliation: Maastricht University
last name: Lisa Müller-Ehrenberg, MSc
phone: 0031433881025
email: l.muller-ehrenberg@maastrichtuniversity.nl
last name: Heidi IL Jacobs, PhD
phone: 0031433884090
email: h.jacobs@maastrichtuniversity.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: Undecided