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Transcutaneous Auricular Vagus Nerve Stimulation for Persistent Post-concussion Symptoms

NCT07017257 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-06-12

No results posted yet for this study

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.

Conditions

  • Persistent Post-concussive Symptoms

Interventions

DEVICE

Active taVNS

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.

DEVICE

Sham taVNS

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.

Sponsors & Collaborators

  • University Hospital Sart Tilman, Liege

    collaborator UNKNOWN

  • University of Liege

    lead OTHER

Principal Investigators

  • Nicolas Lejeune, MD, PhD · NeuroRehab & Consciousness Clinic, Neurology Department , University Hospital of Liège

  • Aurore Thibaut, PT, PhD · NeuroRecovery Lab, GIGA-Consciousness, GIGA Institute, University of Liège

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2027-05-31
Completion
2027-06-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07017257 on ClinicalTrials.gov