<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/NCT03227185</url>
  </required_header>
  <id_info>
    <org_study_id>3351</org_study_id>
    <secondary_id>2016-02175</secondary_id>
    <nct_id>NCT03227185</nct_id>
  </id_info>
  <brief_title>Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Controls and Dementia Patients</brief_title>
  <official_title>Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Young and Elderly Participants as Well as in Individuals With Memory Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bern</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies showed that anodal tDCS applied over the dorsolateral prefrontal cortex&#xD;
      (DLPFC) improved episodic memory performance, indicating a possible use as an intervention&#xD;
      for patients suffering from memory impairments. At the same time, only scant evidence&#xD;
      (provided by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy&#xD;
      (MRS)) exists regarding the underlying mechanisms, thus hindering a more targeted&#xD;
      application.&#xD;
&#xD;
      The present study aims at establishing a connection between the stimulation-induced change in&#xD;
      episodic memory performance on the behavioural level and neurophysiological parameters. TDCS&#xD;
      effects and the underlying mechanisms will be compared between different study conditions,&#xD;
      receiving either real anodal tDCS or sham stimulation over the left dorsolateral prefrontal&#xD;
      cortex during an episodic memory task.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No patients populations included ==&gt; could not be recruited in meaningful numbers to allow&#xD;
    conclusions.&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 19, 2019</completion_date>
  <primary_completion_date type="Actual">October 18, 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>Crossover Assignment</intervention_model>
    <intervention_model_description>Participants will be randomly assigned to two possible sequences of stimulation conditions. Group 1 will receive real tDCS stimulation to the left dlPFC during encoding on the first day and sham stimulation on the second day, and group 2 will receive sham stimulation during encoding on the first day and real tDCS on the second day. The participants will be randomized with equal probability to each of the two groups, using block randomization..</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Episodic memory performance - learning curve</measure>
    <time_frame>0.25 hours</time_frame>
    <description>Number of encoded words during the three consecutive immediate retrievals in the encoding phase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Episodic memory performance - delayed recall 1</measure>
    <time_frame>20 min after encoding phase</time_frame>
    <description>Number of remembered words in the delayed recall after a short delay at the day of the on-site visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Episodic memory performance - delayed recall 2</measure>
    <time_frame>1 day after on-site visit</time_frame>
    <description>Number of remembered words one day after learning</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurotransmitter levels</measure>
    <time_frame>0.5 hours</time_frame>
    <description>Changes in neurotransmitter levels (gamma-Aminobutyric acid (GABA) and glutamatergic metabolites (Glx) due to tDCS (comparing pre- and post-stimulation measurements in DLPFC)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Healthy</condition>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Real - sham anodal tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Session 1: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase.&#xD;
Session 2: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham - real anodal tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Session 1: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase.&#xD;
Session 2: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>real anodal transcranial direct current stimulation (tDCS)</intervention_name>
    <description>The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.</description>
    <arm_group_label>Real - sham anodal tDCS</arm_group_label>
    <arm_group_label>Sham - real anodal tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham transcranial direct current stimulation (tDCS)</intervention_name>
    <description>The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.</description>
    <arm_group_label>Real - sham anodal tDCS</arm_group_label>
    <arm_group_label>Sham - real anodal tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Right-handedness&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Native German speakers or comparable level of fluency&#xD;
&#xD;
          -  Normal or corrected-to-normal vision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological or psychiatric condition (other than diagnosed cognitive impairment)&#xD;
&#xD;
          -  Past head injuries&#xD;
&#xD;
          -  Magnetizable implants&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Current or life-time alcohol or drug abuse&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Skin diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Klöppel, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Old Age Psychiatry and Psychotherapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Old Age Psychiatry and Psychotherapy</name>
      <address>
        <city>Bern</city>
        <zip>3000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</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>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03227185
org study id: 3351
secondary id: 2016-02175
nct id: NCT03227185
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Previous studies showed that anodal tDCS applied over the dorsolateral prefrontal cortex
      (DLPFC) improved episodic memory performance, indicating a possible use as an intervention
      for patients suffering from memory impairments. At the same time, only scant evidence
      (provided by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy
      (MRS)) exists regarding the underlying mechanisms, thus hindering a more targeted
      application.

      The present study aims at establishing a connection between the stimulation-induced change in
      episodic memory performance on the behavioural level and neurophysiological parameters. TDCS
      effects and the underlying mechanisms will be compared between different study conditions,
      receiving either real anodal tDCS or sham stimulation over the left dorsolateral prefrontal
      cortex during an episodic memory task.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Participants will be randomly assigned to two possible sequences of stimulation conditions. Group 1 will receive real tDCS stimulation to the left dlPFC during encoding on the first day and sham stimulation on the second day, and group 2 will receive sham stimulation during encoding on the first day and real tDCS on the second day. The participants will be randomized with equal probability to each of the two groups, using block randomization..
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Episodic memory performance - learning curve
time frame: 0.25 hours
description: Number of encoded words during the three consecutive immediate retrievals in the encoding phase
measure: Episodic memory performance - delayed recall 1
time frame: 20 min after encoding phase
description: Number of remembered words in the delayed recall after a short delay at the day of the on-site visit
measure: Episodic memory performance - delayed recall 2
time frame: 1 day after on-site visit
description: Number of remembered words one day after learning
measure: Neurotransmitter levels
time frame: 0.5 hours
description: Changes in neurotransmitter levels (gamma-Aminobutyric acid (GABA) and glutamatergic metabolites (Glx) due to tDCS (comparing pre- and post-stimulation measurements in DLPFC)
arm group label: Real - sham anodal tDCS
arm group type: Experimental
description: Session 1: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase.
Session 2: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase.
arm group label: Sham - real anodal tDCS
arm group type: Experimental
description: Session 1: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase.
Session 2: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase.
intervention type: Device
intervention name: real anodal transcranial direct current stimulation (tDCS)
description: The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
arm group label: Real - sham anodal tDCS
arm group label: Sham - real anodal tDCS
intervention type: Device
intervention name: sham transcranial direct current stimulation (tDCS)
description: The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
arm group label: Real - sham anodal tDCS
arm group label: Sham - real anodal tDCS
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stefan Klöppel, Prof
role: Principal Investigator
affiliation: University Hospital of Old Age Psychiatry and Psychotherapy
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction
sharing ipd: No