<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/NCT03799458</url>
  </required_header>
  <id_info>
    <org_study_id>CDMRP-PT160096</org_study_id>
    <nct_id>NCT03799458</nct_id>
  </id_info>
  <brief_title>High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury</brief_title>
  <acronym>NAVIGATE-TBI</acronym>
  <official_title>High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biomedical Research Institute of New Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New Jersey Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Mind Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The City College of New York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim 1: To use magnetoencephalography (MEG) and magnetic resonance imaging (MRI) in Veterans&#xD;
      and civilians with mild traumatic brain injury (mTBI) and sensory postconcussive symptoms&#xD;
      (PCS) to demonstrate the mechanism of therapeutic benefit of HD-tDCS for sensory symptoms, as&#xD;
      shown by reliable changes in the activity of the cognitive control network (CCN) and sensory&#xD;
      system network (SSN) following stimulation; Aim 2: this intervention will result in long-term&#xD;
      improvements in measures of executive function, depression/anxiety, and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Experimental Design and Methods Participants: 120 subjects will be recruited for this study&#xD;
      from the NM VA Health Care System and community, 40 healthy controls subjects for an&#xD;
      imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered injury at&#xD;
      least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. All&#xD;
      participants will be 18-59 years of age.&#xD;
&#xD;
      Recruitment: Human participants (ages 18-59) will be invited to come to the University of New&#xD;
      Mexico (UNM) to ask questions prior to providing consent. They will be provided with consent&#xD;
      forms that describe the study procedures and potential risks.&#xD;
&#xD;
      Once informed consent is obtained and the appropriate forms signed, the participant will be&#xD;
      assigned a unique research subject identifier (URSI) number, and from that point forward all&#xD;
      research data will only be labeled with the URSI number. The key linking identifiers of&#xD;
      participants to the URSI will be maintained on a separate database that will be stored behind&#xD;
      locked doors, in a locked filing cabinet in a secure area. All participants may then undergo&#xD;
      demographic data collection, neuropsychological assessments sensory evaluation, at UNM. They&#xD;
      may also undergo MEG and MRI at the Mind Research Network (MRN), located in the same&#xD;
      building.&#xD;
&#xD;
      Demographic Data: As part of the initial assessment, basic demographic data regarding the&#xD;
      subject may be noted down, including age, gender, socioeconomic status, educational&#xD;
      attainment, handedness, use of common stimulants such as caffeine, and brain injury severity.&#xD;
      They may also be asked if they are willing to allow their medical record to be accessed, for&#xD;
      the purposes of confirming details about any traumatic brain injury (TBI) as well as&#xD;
      obtaining results of neuroimaging studies done at the time of injury or afterward. This will&#xD;
      include medical, surgical, neurological and psychiatric history, results of lab tests, brain&#xD;
      scans, electroencephalography tests, medication lists, information from doctor's visits and&#xD;
      hospital visits.&#xD;
&#xD;
      Neuropsychological testing procedures: All neuropsychological testing will be administered in&#xD;
      the Center for Brain Recovery and Repair Core by trained study personnel under direct&#xD;
      supervision of core directors. The following domains and tests will be administered:&#xD;
      Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research&#xD;
      (Examiner); Digit Span; Delis-Kaplan Executive Function Systems (DKEFS) Trail-making Test&#xD;
      Conditions 2 and 4; Hopkins Verbal Learning Test (HVLT); Frontal Systems Behavior Scale&#xD;
      (FrSBe); Test of Memory Malingering (TOMM); Wechsler Test of Adult Reading (WTAR); Digit&#xD;
      Symbol Coding; Handedness; Socioeconomic Status (SES); Patient's Global Impression of Change&#xD;
      (PGIC); Glasgow Outcome Scale-Extended (GOSE).&#xD;
&#xD;
      Sensory Assessment: Hearing, balance, and vision will be assessed using Common Data Element&#xD;
      (CDE) instruments, including the Hearing Handicap Assessment, the Test for Visual Discomfort,&#xD;
      the modified Balance Error Scoring System. Oculomotor control will be assessed using virtual&#xD;
      reality goggles (Oculus) with implanted eye trackers (iScan).&#xD;
&#xD;
      Magnetoencephalography: Magnetoencephalography (MEG) may be done after neuropsychological&#xD;
      testing. The participant will sit in the MEG scanner to record brain magnetic fields. MEG&#xD;
      setup takes between 10 and 30 minutes, and subsequent recording takes one hour. During MEG&#xD;
      assessments participants will complete numerous tasks. Each task is designed to parse&#xD;
      different cognitive mechanisms that contribute to sensory performance. In perceptual tasks,&#xD;
      participants will discriminate tone pitches amongst novel distracting tones (Auditory&#xD;
      Orienting Task; AOT). For eye movement tasks, participants are asked look either towards or&#xD;
      away from a visual stimulus (Pro- and Anti-saccades).&#xD;
&#xD;
      Magnetic resonance imaging (MRI): MRI scan(s) will be obtained for integration with MEG, as&#xD;
      needed for analyses. Total scan time, including participant setup and removal, is expected to&#xD;
      take 1 hour. Participants may lie down on a table and be placed into a long donut-shaped&#xD;
      magnet. During the scan, participants will be asked to rest quietly or to fixate on a dot on&#xD;
      a screen in front of them, or to perform a memory task. No contrast will be used. Any female&#xD;
      over 18 who thinks she may be pregnant will complete a urine pregnancy screen before the MRI&#xD;
      scan.&#xD;
&#xD;
      Following initial testing, the participants in the stimulation arm of the study will receive&#xD;
      10 consecutive weekday sessions of high-definition transcranial direct current stimulation. 2&#xD;
      milliamperes active or sham anodal current will be delivered to the left dorsolateral&#xD;
      prefrontal cortex for 30 minutes. During this time, participants will perform vision therapy&#xD;
      tasks through a virtual reality headset, or a computer-based working memory task. Skin&#xD;
      sensations will be assessed every 10 minutes.&#xD;
&#xD;
      Post stimulation testing: the next available weekday following completion of the study&#xD;
      protocol, subjects will return to UNM to repeat the demographic, neuropsychological, sensory,&#xD;
      and imaging assessments.&#xD;
&#xD;
      Long term followup: At 1 month, 3 months and 6 months after stimulation, subjects will be&#xD;
      contacted via telephone or meet in person, and will be administered the Beck Depression&#xD;
      Inventory (BDI-II), Posttraumatic Stress Disorder Checklist-Military (PCL-M), the&#xD;
      Neurobehavioral Symptom Inventory (NSI), and Patient Global Impression of Change (PGIC)&#xD;
      quality of life assessment tools utilized before and immediately after, after stimulation.&#xD;
      Veterans will undergo these study followup visits at NMVAHCS, and civilians at UNM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2018</start_date>
  <completion_date type="Actual">April 30, 2023</completion_date>
  <primary_completion_date type="Actual">April 30, 2023</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>
    <intervention_model_description>120 subjects will be recruited for this study: 40 healthy controls subjects for the imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered mild TBI at least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. The 80 mTBI subjects will be randomized to either active stimulation (40) or sham stimulation (40).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Active and sham HD-tDCS will be delivered with the same device, and participants and research technician are blinded to the condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postconcussive sensory symptoms</measure>
    <time_frame>2 week visit</time_frame>
    <description>Somatic sub scale score from the Neurobehavioral Symptom Inventory (NSI) (range 0-48; 0-12 mild; 13-24 moderate; 25-36 severe; 37-48 very severe)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Magnetoencephalography peak activation</measure>
    <time_frame>2 week visit</time_frame>
    <description>Peak activation during the Auditory Orienting Task (AOT) performed during magnetoencephalography</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Active Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active HD-tDCS will be delivered while subjects perform sensory training tasks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham HD-tDCS will be delivered while subjects perform sensory training tasks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Imaging Only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>40 subjects will undergo initial testing only as a healthy control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active High-definition transcranial direct current stimulation (HD-tDCS)</intervention_name>
    <description>Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates.</description>
    <arm_group_label>Active Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham High-definition transcranial direct current stimulation (HD-tDCS)</intervention_name>
    <description>Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates</description>
    <arm_group_label>Sham Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. are US Veteran or Active Duty Military personnel aged 18-59,&#xD;
&#xD;
          2. have suffered a mild TBI (alteration in neurological functioning &lt; 24 hours, loss of&#xD;
             consciousness (LOC) less than 30 minutes, Glasgow coma scale (GCS) score (if&#xD;
             available) of between 13 and 15 acutely, and less than 24 hours of post-traumatic&#xD;
             amnesia (PTA));&#xD;
&#xD;
          3. were injured between 3 months and 15 years ago;&#xD;
&#xD;
          4. have post-traumatic sensory symptoms as evidenced by endorsing at least 2 out of 12&#xD;
             sensory symptoms on the Neurobehavioral Symptom Inventory (NSI), a measure of&#xD;
             post-traumatic symptoms from the NIH Common Data Elements (CDE) to a severity of &quot;3&quot;&#xD;
             or higher,&#xD;
&#xD;
          5. are fluent in English,&#xD;
&#xD;
          6. have been on stable doses of any psychotropic medications for the past 2 months.&#xD;
&#xD;
          7. The imaging-only group will have the same inclusion and exclusion criteria except they&#xD;
             will not have had a head injury.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. any history of moderate or severe TBI;&#xD;
&#xD;
          2. a prior history of other neurological disease or any history of seizures beyond&#xD;
             immediate post-traumatic seizure, to as to reduce risk of exacerbation of epilepsy or&#xD;
             other neurological symptoms;&#xD;
&#xD;
          3. history of psychosis, so as to reduce risk of psychiatric decompensation;&#xD;
&#xD;
          4. history of current or recent (within two years) substance/alcohol dependence, to&#xD;
             reduce confounding effects on cognition and plasticity;&#xD;
&#xD;
          5. any discontinuity in skull electrical conductivity (i.e., unhealed burr holes in&#xD;
             scalp) or artificially constructed (metal or plastic) craniotomy cover, to reduce risk&#xD;
             of unimpeded electrical current;&#xD;
&#xD;
          6. presence of any implanted electrical device (e.g. pacemaker), to reduce risk of device&#xD;
             malfunction;&#xD;
&#xD;
          7. recent medical hospitalization (within three weeks), to reduce risk of medical&#xD;
             decompensation during the study;&#xD;
&#xD;
          8. any condition that would prevent the subject from completing the protocol; 9)&#xD;
             appointment of a legal representative, as assessed via direct inquiry of the subject&#xD;
             and a designated trusted other, to avoid coercion of a vulnerable population;&#xD;
&#xD;
        10) any significant blindness, to screen out peripheral sensory damage; 11) any significant&#xD;
        deafness beyond mild hearing loss, to screen out peripheral sensory damage; 12) any ongoing&#xD;
        litigation related to TBI, to prevent interference with legal proceedings; 13) any&#xD;
        contraindication to MRI; 14) membership in an identified vulnerable population, including&#xD;
        minors, pregnant women, and prisoners, so as to prevent coercion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of New Mexico Health Sciences Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</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>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified participant data, including demographic, neuropsychological, and imaging data, will be uploaded to FITBIR for use by TBI researchers, as specified by the grant sponsor.</ipd_description>
    <ipd_time_frame>Data will be uploaded to the Federal Interagency Traumatic Brain Injury Registry (FITBIR) at study termination.</ipd_time_frame>
  </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/NCT03799458
org study id: CDMRP-PT160096
nct id: NCT03799458
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Aim 1: To use magnetoencephalography (MEG) and magnetic resonance imaging (MRI) in Veterans
      and civilians with mild traumatic brain injury (mTBI) and sensory postconcussive symptoms
      (PCS) to demonstrate the mechanism of therapeutic benefit of HD-tDCS for sensory symptoms, as
      shown by reliable changes in the activity of the cognitive control network (CCN) and sensory
      system network (SSN) following stimulation; Aim 2: this intervention will result in long-term
      improvements in measures of executive function, depression/anxiety, and quality of life.
Experimental Design and Methods Participants: 120 subjects will be recruited for this study
      from the NM VA Health Care System and community, 40 healthy controls subjects for an
      imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered injury at
      least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. All
      participants will be 18-59 years of age.

      Recruitment: Human participants (ages 18-59) will be invited to come to the University of New
      Mexico (UNM) to ask questions prior to providing consent. They will be provided with consent
      forms that describe the study procedures and potential risks.

      Once informed consent is obtained and the appropriate forms signed, the participant will be
      assigned a unique research subject identifier (URSI) number, and from that point forward all
      research data will only be labeled with the URSI number. The key linking identifiers of
      participants to the URSI will be maintained on a separate database that will be stored behind
      locked doors, in a locked filing cabinet in a secure area. All participants may then undergo
      demographic data collection, neuropsychological assessments sensory evaluation, at UNM. They
      may also undergo MEG and MRI at the Mind Research Network (MRN), located in the same
      building.

      Demographic Data: As part of the initial assessment, basic demographic data regarding the
      subject may be noted down, including age, gender, socioeconomic status, educational
      attainment, handedness, use of common stimulants such as caffeine, and brain injury severity.
      They may also be asked if they are willing to allow their medical record to be accessed, for
      the purposes of confirming details about any traumatic brain injury (TBI) as well as
      obtaining results of neuroimaging studies done at the time of injury or afterward. This will
      include medical, surgical, neurological and psychiatric history, results of lab tests, brain
      scans, electroencephalography tests, medication lists, information from doctor's visits and
      hospital visits.

      Neuropsychological testing procedures: All neuropsychological testing will be administered in
      the Center for Brain Recovery and Repair Core by trained study personnel under direct
      supervision of core directors. The following domains and tests will be administered:
      Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research
      (Examiner); Digit Span; Delis-Kaplan Executive Function Systems (DKEFS) Trail-making Test
      Conditions 2 and 4; Hopkins Verbal Learning Test (HVLT); Frontal Systems Behavior Scale
      (FrSBe); Test of Memory Malingering (TOMM); Wechsler Test of Adult Reading (WTAR); Digit
      Symbol Coding; Handedness; Socioeconomic Status (SES); Patient's Global Impression of Change
      (PGIC); Glasgow Outcome Scale-Extended (GOSE).

      Sensory Assessment: Hearing, balance, and vision will be assessed using Common Data Element
      (CDE) instruments, including the Hearing Handicap Assessment, the Test for Visual Discomfort,
      the modified Balance Error Scoring System. Oculomotor control will be assessed using virtual
      reality goggles (Oculus) with implanted eye trackers (iScan).

      Magnetoencephalography: Magnetoencephalography (MEG) may be done after neuropsychological
      testing. The participant will sit in the MEG scanner to record brain magnetic fields. MEG
      setup takes between 10 and 30 minutes, and subsequent recording takes one hour. During MEG
      assessments participants will complete numerous tasks. Each task is designed to parse
      different cognitive mechanisms that contribute to sensory performance. In perceptual tasks,
      participants will discriminate tone pitches amongst novel distracting tones (Auditory
      Orienting Task; AOT). For eye movement tasks, participants are asked look either towards or
      away from a visual stimulus (Pro- and Anti-saccades).

      Magnetic resonance imaging (MRI): MRI scan(s) will be obtained for integration with MEG, as
      needed for analyses. Total scan time, including participant setup and removal, is expected to
      take 1 hour. Participants may lie down on a table and be placed into a long donut-shaped
      magnet. During the scan, participants will be asked to rest quietly or to fixate on a dot on
      a screen in front of them, or to perform a memory task. No contrast will be used. Any female
      over 18 who thinks she may be pregnant will complete a urine pregnancy screen before the MRI
      scan.

      Following initial testing, the participants in the stimulation arm of the study will receive
      10 consecutive weekday sessions of high-definition transcranial direct current stimulation. 2
      milliamperes active or sham anodal current will be delivered to the left dorsolateral
      prefrontal cortex for 30 minutes. During this time, participants will perform vision therapy
      tasks through a virtual reality headset, or a computer-based working memory task. Skin
      sensations will be assessed every 10 minutes.

      Post stimulation testing: the next available weekday following completion of the study
      protocol, subjects will return to UNM to repeat the demographic, neuropsychological, sensory,
      and imaging assessments.

      Long term followup: At 1 month, 3 months and 6 months after stimulation, subjects will be
      contacted via telephone or meet in person, and will be administered the Beck Depression
      Inventory (BDI-II), Posttraumatic Stress Disorder Checklist-Military (PCL-M), the
      Neurobehavioral Symptom Inventory (NSI), and Patient Global Impression of Change (PGIC)
      quality of life assessment tools utilized before and immediately after, after stimulation.
      Veterans will undergo these study followup visits at NMVAHCS, and civilians at UNM.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 120 subjects will be recruited for this study: 40 healthy controls subjects for the imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered mild TBI at least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. The 80 mTBI subjects will be randomized to either active stimulation (40) or sham stimulation (40).
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Active and sham HD-tDCS will be delivered with the same device, and participants and research technician are blinded to the condition.
measure: Postconcussive sensory symptoms
time frame: 2 week visit
description: Somatic sub scale score from the Neurobehavioral Symptom Inventory (NSI) (range 0-48; 0-12 mild; 13-24 moderate; 25-36 severe; 37-48 very severe)
measure: Magnetoencephalography peak activation
time frame: 2 week visit
description: Peak activation during the Auditory Orienting Task (AOT) performed during magnetoencephalography
arm group label: Active Stimulation
arm group type: Active Comparator
description: Active HD-tDCS will be delivered while subjects perform sensory training tasks.
arm group label: Sham Stimulation
arm group type: Sham Comparator
description: Sham HD-tDCS will be delivered while subjects perform sensory training tasks.
arm group label: Imaging Only
arm group type: No Intervention
description: 40 subjects will undergo initial testing only as a healthy control group.
intervention type: Device
intervention name: Active High-definition transcranial direct current stimulation (HD-tDCS)
description: Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates.
arm group label: Active Stimulation
intervention type: Device
intervention name: Sham High-definition transcranial direct current stimulation (HD-tDCS)
description: Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates
arm group label: Sham Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: De-identified participant data, including demographic, neuropsychological, and imaging data, will be uploaded to FITBIR for use by TBI researchers, as specified by the grant sponsor.
ipd time frame: Data will be uploaded to the Federal Interagency Traumatic Brain Injury Registry (FITBIR) at study termination.