Ear (auricular) vagus nerve stimulation for persistent post-concussion symptoms
Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Persistent Post-concussion Symptoms: a Randomized Double-blind Controlled Trial
This will test whether gentle electrical stimulation of the ear's vagus nerve can reduce ongoing symptoms in adults who still have problems after a concussion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Liege Academic / other |
| Locations | 1 site (Liège, Liège) |
| Trial ID | NCT07017257 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, sham-controlled trial will enroll 48 adults aged 18–65 with persistent post-concussive symptoms 4 weeks to 1 year after a concussion. Participants are randomized to active transcutaneous auricular vagus nerve stimulation (taVNS) or sham and will complete 15 stimulation sessions over two weeks, including two clinic visits at the University Hospital of Liège and 13 home sessions. Outcomes include symptom questionnaires (headache, mood, sleep, quality of life), neuropsychological tests of attention, working memory and executive function, and neurophysiological measures such as high-density EEG. The study uses a commercially produced taVNS device and is designed to measure both direct (acute) and cumulative neurophysiological and clinical effects.
Who should consider this trial
Good fit: Adults 18–65 who had a concussion 4 weeks to 1 year earlier, score at least 16 on the Rivermead Post-Concussion Questionnaire, have intact skin at the ear electrode site, and no incompatible implants or untreated major neurological/psychiatric conditions are the best candidates.
Not a fit: People with active implanted devices (e.g., pacemaker), recent myocardial infarction or serious cardiac arrhythmia, untreated chronic neurological or psychiatric disorders, pregnancy or breastfeeding, recent heavy alcohol or drug use, or those outside the 4-week to 1-year post-concussion window are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If effective, taVNS could reduce headaches, cognitive and mood symptoms, and improve sleep and daily functioning for people with lingering post-concussion problems.
How similar studies have performed: Small trials of taVNS in mood, pain, and cognitive disorders have produced mixed but promising results, while use specifically for persistent post-concussion symptoms is relatively novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 65; * Between 4 weeks and 1-year post-diagnosis of a concussion; * Score equal or above 16 on the Rivermead Post-Concussion Questionnaire; * Intact skin at the electrode site. Exclusion Criteria: * History of chronic neurological or psychological disorders (still untreated 6 months preceding inclusion); * Pregnancy or breastfeeding; * Presence of an active implant (e.g., pacemaker, cochlear implant); * History of myocardial infarction or cardiac arrhythmia; * Excessive alcohol consumption (\> 14 drinks per week) and/or drug (\> 1x/week) use within the past 6 months.
Where this trial is running
Liège, Liège
- University Hospital of Liège — Liège, Liège, Belgium (Recruiting)
Study contacts
- Principal investigator: Nicolas Lejeune, MD, PhD — NeuroRehab & Consciousness Clinic, Neurology Department , University Hospital of Liège
- Study coordinator: Mélanie Louras, MSc
- Email: melanie.louras@uliege.be
- Phone: +32479925739
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.