Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury
Condition: Traumatic Brain Injury; Post Concussive Symptoms; Depression; Executive Dysfunction
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Wounds and Injuries; Depression
Study type: Interventional

Summary: 
      Patients with mild-moderate traumatic brain injury (TBI) sustained between 3 months and 5
      years ago with prolonged postconcussive symptoms will be recruited. On Day 1 of the study
      they will undergo neuropsychological (NP) testing. They will then undergo 10 days of Left
      dorsolateral prefrontal (DLPFC) anodal transcranial direct current stimulation (TDCS) (active
      or sham) combined with cognitive training. On day 10 NP testing will be obtained again. On
      Day 30, NP testing will be repeated a 3rd time. At 6 months and 1 year, quality of life,
      depression, and post concussive symptoms will be assessed.
    

Detailed description: 
      Our long-term goal is to develop safe and effective treatments for symptoms of mild to
      moderate TBI (mmTBI) that restore patients to higher levels of functioning, decrease
      disability, and promote brain healing. The objective of this application is to investigate
      the use of transcranial direct current stimulation (tDCS) to treat symptoms of executive
      dysfunction and depression in patients with mmTBI. Our central hypotheses are (1) tDCS paired
      with relevant cognitive training facilitates improves executive function on National
      Institutes of Health (NIH)-approved neuropsychological measures, (2) tDCS reduces depression
      scores on NIH Common Data Elements for TBI, (3) that these improvements in emotion and
      cognition will be detectable up to one year after stimulation, and (4) certain clinical
      variables will reliably predict response to tDCS. These objectives were formulated based on
      our clinical experience with Dr. Ronald Yeo (project mentor) characterizing symptomatic
      patients with mmTBI in the post-acute setting and groundbreaking research led by Dr. Vincent
      Clark (project mentor) that has demonstrated robust increases in attention and learning with
      tDCS.

      Specific Aim 1: tDCS for executive dysfunction in mmTBI Experiments in this aim will test the
      hypothesis that in patients with mmTBI, left prefrontal anodal tDCS concurrent with cognitive
      training for ten consecutive weekdays will result in significantly more improvement in
      executive function compared to sham stimulation. Patients with cognitive complaints 3 months
      to 2 years after mmTBI will be recruited from local emergency departments and brain injury
      clinics. Aim 1.1: tDCS will be paired with computer-based cognitive training tasks of
      response inhibition, set shifting, and working memory, while executive function will be
      measured with the NIH Examiner battery before, immediately after, and one month after
      stimulation. Aim 1.2: Persistence of post-traumatic symptom reduction and quality of life
      improvement will be assessed with Common Data Elements instruments via telephone interview at
      6 months and one year. Aim 1.3: Clinical predictors of tDCS response including injury
      severity, premorbid intelligence, and post-traumatic symptom burden will be determined with
      linear mixed-models analysis.

      Specific Aim 2: tDCS for depressive symptoms in mmTBI Experiments in this aim will test the
      hypothesis that left prefrontal anodal tDCS in patients with mmTBI will significantly reduce
      depressive symptoms compared to sham stimulation. Aim 2.1: Patients will be assessed for
      symptoms of depression via self-report instruments and clinician-administered scales from NIH
      Common Data Elements before, immediately after, and one month after the stimulation protocol.
      Aim 2.2: Persistence of antidepressant benefit will be assessed via telephone interview at 6
      months and one year. Aim 2.3: clinical predictors of tDCS response such as injury severity,
      premorbid intelligence, and symptom burden will be determined.
    

Intervention name(s): Anodal tDCS; Cognitive training
Intervention type(s): Device; Behavioral
Intervention description(s): Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.; Cognitive training involves solving executive function tasks on a computer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: traumatic brain injury; post concussive symptoms; depression; executive dysfunction; brain stimulation