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NOT YET RECRUITING
NCT07517172
NA

Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study

Sponsor: University of Minnesota

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blind, sham-controlled feasibility trial designed to assess the acceptability and preliminary efficacy of Transcutaneous Auricular Neurostimulation (tAN) for individuals with Temporomandibular Disorders (TMD). Approximately 40 participants will be enrolled to evaluate whether daily, home-based tAN sessions-which deliver mild electrical pulses to the auricular branch of the vagus nerve-can effectively reduce chronic orofacial pain and improve associated cognitive and psychosocial dysfunctions. The study monitors feasibility through retention and adherence rates while tracking secondary outcomes such as pain intensity, cognitive flexibility, and mood changes using validated scales and wearable smartwatch data . Ultimately, this research aims to generate the critical data necessary to inform larger clinical trials and potentially offer a non-pharmacological, non-invasive treatment option for patients refractory to traditional TMD therapies.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-04-01

Completion Date

2027-09-30

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DEVICE

Transcutaneous Auricular Neurostimulation

The intervention in this study is Transcutaneous Auricular Neurostimulation (tAN), a noninvasive neuromodulation technique that delivers mild electrical stimulation to the auricular branch of the vagus nerve (ABVN) via electrodes placed on the external ear.

DEVICE

Sham Stimulation

the sham condition will mimic active stimulation without delivering therapeutically active parameters, defined as electrical stimulation being provided to the earpiece electrode. The sham stimulation will be passive stimulation meaning that no electrical stimulation will be provided to the participant.

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States