Transcutaneous 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
University of Liege
48 participants
May 28, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients will receive active taVNS for 15 consecutive days, with each session lasting 30 minutes. The stimulation will target the cymba conchae of the left ear and will consist of alternating 30-second on and 30-second off periods. The current intensity will range from 1 to 3 mA, adjusted to the patient's pain threshold, with a pulse width of 250 μsec and a frequency of 25Hz.
Patients will receive sham taVNS for 15 consecutive days, with each session lasting 30 minutes. The stimulation will target the cymba conchae of the left ear and will consist of alternating 30-second on and 30-second off periods. The current intensity will be fixed at 100 µA, with a pulse width of 250 μsec and a frequency of 25 Hz.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07017257