Ear (auricular) vagus nerve stimulation for persistent post-concussion symptoms
Official title: Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Persistent Post-concussion Symptoms: a Randomized Double-blind Controlled Trial
Run by University of Liege · NCT07017257 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | University of Liege Academic / other |
| Locations | 1 site (Liège, Liège) |
| Status | Recruiting |
| Started | May 28, 2025 |
| Main results expected | May 2027 |
| Study ends | June 2027 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT07017257 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.