Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Persistent Post-concussion Symptoms: a Randomized Double-blind Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
University Hospital of Liège
RECRUITING
Liège
Contact Information
Primary
Mélanie Louras, MSc
melanie.louras@uliege.be
+32479925739
Backup
Aurore Thibaut, PT, PhD
athibaut@uliege.be
+3243233612
Time Frame
Start Date: 2025-05-28
Estimated Completion Date: 2027-06
Participants
Target number of participants: 48
Treatments
Experimental: Active taVNS
Patients will undergo 15 sessions of 30-min active taVNS applied to the cymba conchae of the left ear. Clinical assessments-including symptom severity questionnaires and neuropsychological tests-along with neurophysiological recordings (hd-EEG and electrocardiography) will be conducted on the first (S1) and final (S15) days of the intervention. The remaining 13 sessions (S2-14) will be self-administered by patients at home.~To monitor safety, participants will report any side effects after each session.~To monitor adherence, the device will record the time and duration of each stimulation session. Blinding efficacy will be evaluated at the end of the intervention by asking participants to indicate whether they believe they received active or sham stimulation, and to rate their confidence in that response.~A follow-up assessment will occur one month after the intervention, during which symptom severity questionnaires will be administered via a phone interview.
Sham_comparator: Sham taVNS
Patients will undergo 15 sessions of 30-min sham taVNS applied to the cymba conchae of the left ear. Clinical assessments-including symptom severity questionnaires and neuropsychological tests-along with neurophysiological recordings (hd-EEG and electrocardiography) will be conducted on the first (S1) and final (S15) days of the intervention. The remaining 13 sessions (S2-14) will be self-administered by patients at home.~To monitor safety, participants will report any side effects after each session.~To monitor adherence, the device will record the time and duration of each stimulation session. Blinding efficacy will be evaluated at the end of the intervention by asking participants to indicate whether they believe they received active or sham stimulation, and to rate their confidence in that response.~A follow-up assessment will occur one month after the intervention, during which symptom severity questionnaires will be administered via a phone interview.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Sart Tilman, Liege
Leads: University of Liege

This content was sourced from clinicaltrials.gov