High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Active High-definition transcranial direct current stimulation (HD-tDCS); Sham High-definition transcranial direct current stimulation (HD-tDCS)
Intervention type(s): Device; Device
Intervention description(s): 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.; 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
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).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment