Noninvasive Brain Stimulation to Enhance Cognition at Home Following a TBI.

Enhancing Cognition After TBI Using Noninvasive Vagus Nerve Stimulation at Home

The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous vagus nerve stimulation (tVNS) at home, to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).

This is a single-blind, open-label pilot study to evaluate the feasibility and preliminary efficacy of remotely supervised, at-home delivery of tVNS in individuals with moderate to severe TBI during the post-acute recovery phase. Eligible participants will complete a 2-week tVNS intervention protocol at home. Mixed methods (quantitative and qualitative) will be used to evaluate outcomes. Eligible participants will be invited to initial baseline assessment and tVNS training session (Visit 1). Then, they will complete two weeks of at-home administration period. Lastly, they will return to a post- stimulation assessment (Visit 2). In the assessment sessions participants will complete tasks of set shifting and working memory, core executive functions, as well as complete surveys regarding fatigue, sleep, and overall quality of life.

Inclusion Criteria:

• Age 18-75 years.

  • Formally diagnosed with traumatic brain injury.
  • Ability to independently use a keyboard.
  • Able to understand and communicate in English (according to clinical judgment).
  • Able to independently provide consent to participate.

Exclusion Criteria:

• Acute medical issues requiring close physician or nursing monitoring.

  • Bioelectrical implants, cerebral shunts, including pacemakers.
  • Anyone with sore or diseased skin area in the ear
  • Pregnancy or persons who are lactating.
  • Cardiac arrhythmia.
  • Epilepsy or seizure disorders.
  • Significant gross or fine motor weakness.
  • Significant, ongoing communication or comprehension impairments (such as aphasia) that would affect an individual's ability to complete the required assessments.
  • Severely impaired memory retention (Score lower than 3 in the 3 Word Delayed Recall test attached to this submission).
  • Current major depression diagnosis.