Using noninvasive nerve stimulation to improve cognitive recovery after brain injury
Enhancing Cognitive Rehabilitation After TBI Using Noninvasive Vagal Nerve Stimulation
This study is testing if a noninvasive nerve stimulation treatment can help people with mild to moderate brain injuries improve their thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06589362 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and preliminary efficacy of transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild to moderate traumatic brain injury (TBI). Participants will undergo two sessions, spaced 2-7 days apart, where they will receive either active tVNS or sham stimulation while performing executive function tasks. The order of stimulation will be counterbalanced to ensure a rigorous assessment of the intervention's effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who are currently in inpatient rehabilitation for recent mild to moderate traumatic brain injury.
Not a fit: Patients with significant communication impairments or acute medical issues requiring close monitoring may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive recovery outcomes for patients with traumatic brain injury.
How similar studies have performed: While the use of vagus nerve stimulation is gaining interest, this specific application in cognitive rehabilitation for TBI is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Shira Cohen-Zimerman, PhD — Shirley Ryan AbilityLab
- Study coordinator: Shira Cohen-Zimerman, PhD
- Email: sohenzime@sralab.org
- Phone: 3122386450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.