<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/NCT01681589</url>
  </required_header>
  <id_info>
    <org_study_id>11-00685</org_study_id>
    <nct_id>NCT01681589</nct_id>
  </id_info>
  <brief_title>Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)</brief_title>
  <official_title>Relationship Between Attention and Emotional Regulation Post-TBI: Probing Neural Circuitry With Transcranial Direct Current Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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>
      The purpose of this pilot study is to investigate the relationship between attention and&#xD;
      emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the&#xD;
      cognitive mechanisms of emotional processing in patients with TBI, and explore novel&#xD;
      treatment strategies to improve emotional regulation using with transcranial direct current&#xD;
      stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty (30) individuals status post TBI with complaints of emotional dysfunction 6 months&#xD;
      post-brain injury and Fifteen (15) healthy controls will participate in the study. The&#xD;
      experimental group will receive active tDCS for 20 minutes and computerized cognitive&#xD;
      training twice a week for 30-45 minutes for 6 weeks as described below. The control group&#xD;
      will receive sham-tDCS 20 minutes and computerized cognitive training for 30-45 minutes twice&#xD;
      a week for 6 weeks (12 training sessions). The sham group will not receive real tDCS after&#xD;
      completion of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">June 2019</completion_date>
  <primary_completion_date type="Actual">June 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Baseline Measures Before Treatment</measure>
    <time_frame>Week 1</time_frame>
    <description>Patients meeting criteria to particpate in the study will be tested at baseline. During Visit 1, patients will be tested to measure how alert they are, their ability to perform actions one after the other and other mental functions. On Visit 2, patients will be tested on your ability to control your emotions. On Visit 3, patients will have a brain scan (MRI) to help the investigators understand how various parts of your brain are connected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post Treatment Measures to Check Improvements</measure>
    <time_frame>Week 8</time_frame>
    <description>Testing will be done again at the end of 6 weeks. This will allow the investigators to determine if there have been improvements in the patients attention and emotional function. The same assessments will be repeated again as with Visits 1-3. Investigators will ask questions regarding patients emotional well-being. An MRI will once again be performed.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transcranial Direct Current Stimulator (TDCS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Fifteen (15) healthy control subjects will participate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Direct Current Stimulator (TDCS)</intervention_name>
    <description>Group will receive active TDCS</description>
    <arm_group_label>Transcranial Direct Current Stimulator (TDCS)</arm_group_label>
    <other_name>Fisher Wallace Cranial Stimulator</other_name>
    <other_name>The Fisher Wallace Stimulator, Model FW-100</other_name>
    <other_name>FDA 510 (K)Cleared number K903654</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>This group will receive Sham TDCS</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Healthy Control Group</intervention_name>
    <description>Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.</description>
    <arm_group_label>Healthy Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Brain Injury at least 6 months prior&#xD;
&#xD;
          -  Family or self-identification of cognitive or emotional difficulties&#xD;
&#xD;
          -  Unchanged and stabilized medical treatment in the three weeks prior to the screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any social or medical problem that precludes completion of the protocol.&#xD;
&#xD;
          -  Presence of focal motor deficits in the upper extremities.&#xD;
&#xD;
          -  Comorbid psychiatric disease such as schizophrenia, or active substance abusers&#xD;
             (except nicotine).&#xD;
&#xD;
          -  History of craniectomy, active infection, or seizure activity beyond 1 week post-TBI.&#xD;
&#xD;
          -  Complicating medical problems such as uncontrolled hypertension, diabetes with signs&#xD;
             of neuropathy, and previous neurological illness such as head trauma, prior stroke,&#xD;
             epilepsy or demyelinating disease, implanted neuromodulatory or electronic device,&#xD;
             metal in head&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prin Amorapanth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <results_first_submitted>August 6, 2020</results_first_submitted>
  <results_first_submitted_qc>August 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2020</results_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TBI</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT01681589/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Control Group</title>
          <description>The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).&#xD;
Control Group: This group will receive Sham TDCS</description>
        </group>
        <group group_id="P2">
          <title>Transcranial Direct Current Stimulator (TDCS)</title>
          <description>The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.&#xD;
Transcranial Direct Current Stimulator (TDCS): Group will receive active TDCS</description>
        </group>
        <group group_id="P3">
          <title>Healthy Control Group</title>
          <description>Fifteen (15) healthy control subjects will participate.&#xD;
Healthy Control Group: Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.</population>
      <group_list>
        <group group_id="B1">
          <title>Control Group</title>
          <description>The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).&#xD;
Control Group: This group will receive Sham TDCS</description>
        </group>
        <group group_id="B2">
          <title>Transcranial Direct Current Stimulator (TDCS)</title>
          <description>The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.&#xD;
Transcranial Direct Current Stimulator (TDCS): Group will receive active TDCS</description>
        </group>
        <group group_id="B3">
          <title>Healthy Control Group</title>
          <description>Fifteen (15) healthy control subjects will participate.&#xD;
Healthy Control Group: Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                </category>
                <category>
                  <title>Asian</title>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                </category>
                <category>
                  <title>Black or African American</title>
                </category>
                <category>
                  <title>White</title>
                </category>
                <category>
                  <title>More than one race</title>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Baseline Measures Before Treatment</title>
        <description>Patients meeting criteria to particpate in the study will be tested at baseline. During Visit 1, patients will be tested to measure how alert they are, their ability to perform actions one after the other and other mental functions. On Visit 2, patients will be tested on your ability to control your emotions. On Visit 3, patients will have a brain scan (MRI) to help the investigators understand how various parts of your brain are connected.</description>
        <time_frame>Week 1</time_frame>
        <population>The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).&#xD;
Control Group: This group will receive Sham TDCS</description>
          </group>
          <group group_id="O2">
            <title>Transcranial Direct Current Stimulator (TDCS)</title>
            <description>The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.&#xD;
Transcranial Direct Current Stimulator (TDCS): Group will receive active TDCS</description>
          </group>
          <group group_id="O3">
            <title>Healthy Control Group</title>
            <description>Fifteen (15) healthy control subjects will participate.&#xD;
Healthy Control Group: Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Measures Before Treatment</title>
          <description>Patients meeting criteria to particpate in the study will be tested at baseline. During Visit 1, patients will be tested to measure how alert they are, their ability to perform actions one after the other and other mental functions. On Visit 2, patients will be tested on your ability to control your emotions. On Visit 3, patients will have a brain scan (MRI) to help the investigators understand how various parts of your brain are connected.</description>
          <population>The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post Treatment Measures to Check Improvements</title>
        <description>Testing will be done again at the end of 6 weeks. This will allow the investigators to determine if there have been improvements in the patients attention and emotional function. The same assessments will be repeated again as with Visits 1-3. Investigators will ask questions regarding patients emotional well-being. An MRI will once again be performed.</description>
        <time_frame>Week 8</time_frame>
        <population>The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).&#xD;
Control Group: This group will receive Sham TDCS</description>
          </group>
          <group group_id="O2">
            <title>Transcranial Direct Current Stimulator (TDCS)</title>
            <description>The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.&#xD;
Transcranial Direct Current Stimulator (TDCS): Group will receive active TDCS</description>
          </group>
          <group group_id="O3">
            <title>Healthy Control Group</title>
            <description>Fifteen (15) healthy control subjects will participate.&#xD;
Healthy Control Group: Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Post Treatment Measures to Check Improvements</title>
          <description>Testing will be done again at the end of 6 weeks. This will allow the investigators to determine if there have been improvements in the patients attention and emotional function. The same assessments will be repeated again as with Visits 1-3. Investigators will ask questions regarding patients emotional well-being. An MRI will once again be performed.</description>
          <population>The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 years</time_frame>
      <desc>The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. Data transfer was not ideal, and no study data are available.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Group</title>
          <description>The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).&#xD;
Control Group: This group will receive Sham TDCS</description>
        </group>
        <group group_id="E2">
          <title>Transcranial Direct Current Stimulator (TDCS)</title>
          <description>The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.&#xD;
Transcranial Direct Current Stimulator (TDCS): Group will receive active TDCS</description>
        </group>
        <group group_id="E3">
          <title>Healthy Control Group</title>
          <description>Fifteen (15) healthy control subjects will participate.&#xD;
Healthy Control Group: Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prin Amorapanth, MD, PhD</name_or_title>
      <organization>NYU Langone Health</organization>
      <phone>212-263-6037</phone>
      <email>Prin.Amoropanth@nyulangone.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01681589
org study id: 11-00685
nct id: NCT01681589
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this pilot study is to investigate the relationship between attention and
      emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the
      cognitive mechanisms of emotional processing in patients with TBI, and explore novel
      treatment strategies to improve emotional regulation using with transcranial direct current
      stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.
Thirty (30) individuals status post TBI with complaints of emotional dysfunction 6 months
      post-brain injury and Fifteen (15) healthy controls will participate in the study. The
      experimental group will receive active tDCS for 20 minutes and computerized cognitive
      training twice a week for 30-45 minutes for 6 weeks as described below. The control group
      will receive sham-tDCS 20 minutes and computerized cognitive training for 30-45 minutes twice
      a week for 6 weeks (12 training sessions). The sham group will not receive real tDCS after
      completion of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Baseline Measures Before Treatment
time frame: Week 1
description: Patients meeting criteria to particpate in the study will be tested at baseline. During Visit 1, patients will be tested to measure how alert they are, their ability to perform actions one after the other and other mental functions. On Visit 2, patients will be tested on your ability to control your emotions. On Visit 3, patients will have a brain scan (MRI) to help the investigators understand how various parts of your brain are connected.
measure: Post Treatment Measures to Check Improvements
time frame: Week 8
description: Testing will be done again at the end of 6 weeks. This will allow the investigators to determine if there have been improvements in the patients attention and emotional function. The same assessments will be repeated again as with Visits 1-3. Investigators will ask questions regarding patients emotional well-being. An MRI will once again be performed.
arm group label: Control Group
arm group type: Sham Comparator
description: The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).
arm group label: Transcranial Direct Current Stimulator (TDCS)
arm group type: Experimental
description: The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.
arm group label: Healthy Control Group
arm group type: Other
description: Fifteen (15) healthy control subjects will participate.
intervention type: Device
intervention name: Transcranial Direct Current Stimulator (TDCS)
description: Group will receive active TDCS
arm group label: Transcranial Direct Current Stimulator (TDCS)
other name: Fisher Wallace Cranial Stimulator
other name: The Fisher Wallace Stimulator, Model FW-100
other name: FDA 510 (K)Cleared number K903654
intervention type: Device
intervention name: Control Group
description: This group will receive Sham TDCS
arm group label: Control Group
intervention type: Other
intervention name: Healthy Control Group
description: Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.
arm group label: Healthy Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Prin Amorapanth, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 