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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
tVNS stimulation, one hour a day, for 14 days.
Shirley Ryan AbilityLab
Chicago, Illinois, United States
Number of participants who successfully completed 75% of the sessions.
Recording the number of participant who completed at least 75% of the sessions out of the number of participants enrolled in the study.
Time frame: Day 15
Participant-Reported Acceptability of Home-Based tVNS Therapy
Completion of the Treatment Acceptability/Adherence Scale at baseline (day 0) and post stimulation assessment (day 15)
Time frame: Day 0 and Day 15
N-Back task
In the N-Back Task, participants are presented a series of visual stimuli. They are asking for each stimulus whether is matches a stimulus n-trials before. For example, in a 2-back task, in which the trials consist of letters, participants have to decide whether the current letter is the same as the letter in the trial n-2. We will use a computerized version of this task.
Time frame: Day 0 Baseline and Day 15 Post Stimulation Assessment
California Verbal Learning Test
The California Verbal Learning Test evaluates the ability to encode, recall, and recognize verbally presented information across multiple learning trials and delayed recall conditions. Participants are read multiple lists of words and asked to recall specific words at different time allotments.
Time frame: Day 0 Baseline and Day 15 Post Stimulation Assessment
Trail Making Test A&B
Trail Making Part A requires participant to draw a line between circles containing numbers in ascending order. Part B requires participants to alternate drawing a line between ascending letters and numbers. The key measures are the time required to complete and the number of errors made in Part A and Part B. The test measures various aspects of cognition including attention, visual search, motor coordination, reasoning, and task switching.
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Time frame: Day 0 Baseline and Day 15 Post Stimulation Assessment