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Recruiting NCT07017257

NCT07017257 Transcutaneous Auricular Vagus Nerve Stimulation for Persistent Post-concussion Symptoms

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Clinical Trial Summary
NCT ID NCT07017257
Status Recruiting
Phase
Sponsor University of Liege
Condition Persistent Post-concussive Symptoms
Study Type INTERVENTIONAL
Enrollment 48 participants
Start Date 2025-05-28
Primary Completion 2027-05

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
Active taVNSSham taVNS

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 48 participants in total. It began in 2025-05-28 with a primary completion date of 2027-05.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Persistent post-concussive symptoms (PPCS) affect a significant proportion of individuals following a concussion, leading to debilitating impacts on their quality of life and work capacity. Currently, effective treatments for PPCS are limited, despite their lasting and debilitating impact. Transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive neuromodulation technique, holds promise as a therapeutic option by leveraging the bottom-up modulation of brain activity via the auricular branch of the vagus nerve. This study aims to evaluate the neurophysiological and clinical effects of taVNS on brain activity and symptomatology in patients with PPCS through a randomized, controlled, double-blind trial.

Eligibility 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.

Contact & Investigator

Central Contact

Mélanie Louras, MSc

✉ melanie.louras@uliege.be

📞 +32479925739

Principal Investigator

Nicolas Lejeune, MD, PhD

PRINCIPAL INVESTIGATOR

NeuroRehab & Consciousness Clinic, Neurology Department , University Hospital of Liège

Frequently Asked Questions

Who can join the NCT07017257 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Persistent Post-concussive Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07017257 currently recruiting?

Yes, NCT07017257 is actively recruiting participants. Contact the research team at melanie.louras@uliege.be for enrollment information.

Where is the NCT07017257 trial being conducted?

This trial is being conducted at Liège, Belgium.

Who is sponsoring the NCT07017257 clinical trial?

NCT07017257 is sponsored by University of Liege. The principal investigator is Nicolas Lejeune, MD, PhD at NeuroRehab & Consciousness Clinic, Neurology Department , University Hospital of Liège. The trial plans to enroll 48 participants.

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