Study of Noninvasive Ear Nerve Stimulation to Treat Pain from Temporomandibular Disorder in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the use of Transcutaneous Auricular Neurostimulation tAN as a noninvasive treatment for chronic Temporomandibular Disorders TMD. This randomized, double-blind, sham-controlled feasibility trial aims to assess how acceptable and effective daily home-based tAN sessions are in reducing chronic orofacial pain and improving cognitive and psychosocial functions in adults with TMD. The study will enroll about 40 participants and is designed to gather crucial data to support future larger trials. Participants will be assigned to either an active tAN group or a sham stimulation group. After initial assessments, they will be trained to self-administer the assigned treatment at home daily for at least two hours, with a maximum of 24 hours. The active tAN delivers mild electrical pulses to the auricular branch of the vagus nerve via electrodes on the ear, while the sham device mimics the experience without delivering electrical stimulation. Device usage, adherence, and side effects will be tracked through internal logs. Throughout the study, participants will be monitored for retention, adherence, and acceptability of the intervention at specific time points weeks 4 and 6. Secondary measures include evaluating pain intensity, cognitive flexibility, and mood using validated scales and wearable smartwatch data. Participants will complete surveys and check-ins electronically, with all data collected to inform the potential of tAN as a non-pharmacological option for managing TMD pain.

Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study