Traumatic Brain Injury
Conditions
Brief summary
The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).
Detailed description
Eligible participants will be invited to two sessions, 2-7 days apart. In each session, either active tVNS or sham stimulation will be administered while the participants are performing tasks of executive functions. The order of the sessions (tVNS vs Sham) will be counterbalanced across participants.
Interventions
DEVICETranscutaneous auricular vagus active nerve stimulation
In the active stimulation, two electrodes are placed in the cymba conchae of one of the ears, an area thought to be exclusively innervated by the auricular branch of the vagus nerve.
DEVICETranscutaneous auricular vagus sham nerve stimulation
In the sham stimulation, the electrodes are placed on the tail of helix, which is free of vagal innervation.
Sponsors
Shirley Ryan AbilityLab
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
a single-blind sham-controlled randomized crossover pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
In inpatient rehabilitation due to recent Traumatic Brain Injury, ages 18-65 years. Ability to independently use a keyboard. Able to understand and communicate in English (according to clinical judgment). Able to independently provide consent to participate. Orientation to place, time, and situation (two consecutive scores of 25 or more on the Orientation Log(O-Log)40. This scale is routinely administered during acute rehabilitation stay.
Exclusion criteria
Acute medical issues requiring close physician or nursing monitoring. Bioelectrical implants, including pacemakers. Pregnancy or persons who are lactating. 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. Acute agitation or behavioral issues, as defined by a last Agitated Behavior Scale Score greater than 21 (routinely administered during acute rehabilitation stay, that would affect an individual's ability to participate in the required assessments. Severely impaired memory retention (Score lower than 3 in the 3 Word Delayed Recall test, routinely administered during acute rehabilitation stay. Diagnosis of depression. Active substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| N-Back Computerized Task | 15 minutes | In the n-back task, participants are presented a series of visual stimuli. They are asked for each stimulus whether it 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 trial n - 2. We will use a computerized version of this task. |
| Trail Making Test - Parts A & B | 5 minutes | Trail Making Part A requires participants to draw a line between circles containing numbers in ascending order (e.g., 1-2- 3...etc.). Part B requires participants to alternate drawing a line between ascending letters and numbers (e.g., 1-A-2-B...etc.). The key measures are the time required to complete and the number of errors made in Part A and Part B. This test measures various aspects of cognition including attention, visual search, motor coordination, reasoning, and task-switching. |
Countries
United States
Contacts
Primary ContactShira Cohen-Zimerman, PhD
Backup ContactKaty Magee, M.H.S
Outcome results
None listed