Noninvasive Brain Stimulation to Enhance Cognition at Home Following a TBI. (NCT07428980) | Clinical Trial Compass
CompletedNot Applicable
Noninvasive Brain Stimulation to Enhance Cognition at Home Following a TBI.
United States7 participantsStarted 2026-01-09
Plain-language summary
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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a home-based brain stimulation device called tVNS after TBI — since the trial is now completed, has my care team seen any of its results, and does the data suggest it was safe and well-tolerated enough to consider for someone in my situation?
2The trial measured whether participants could complete at least 75% of the sessions at home — what does that tell us about how demanding this kind of treatment schedule might be, and do you think I'd realistically be able to keep up with it given my current recovery?
3Since this was a Phase NA feasibility study, it was designed to test whether the approach works in practice rather than prove it treats TBI — does that mean we still don't have strong evidence it improves cognition, and should I be looking at more established therapies first?
4The trial also measured how acceptable participants found the home-based tVNS experience — is there any published or available data from this study yet that you could review with me before we discuss whether this type of treatment makes sense for my recovery plan?
5Are there follow-on trials building on this completed study that might be enrolling now, or would you recommend a different cognitive rehabilitation approach while we wait for more evidence from this line of research?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants who successfully completed 75% of the sessions.
Timeframe: Day 15
2
Participant-Reported Acceptability of Home-Based tVNS Therapy