Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study
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, h
| Condition(s) | Temporomandibular Disorder |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: * Age 18 to 65 years. * Diagnosis of temporomandibular disorder (TMD) based on the Diagnostic Criteria for Temporomandibular Disorders (DC-TMD). * Pain intensity of at least 4/10 on the Numeric Rating Scale (NRS) over the past two weeks. * Chronic pain duration of at least three months, consistent with diagnosis of chronic TMD. * Willingness to self-administer transcutaneous auricular nerve stimulation (tAN) at home and comply with study procedures. * Fluency in English to ensure comprehension of study materials and assessments. * Access to a smartphone or computer with internet to complete electronic study surveys and check-ins with the research team. Exclusion Criteria: * Neurological conditions that may interfere with study outcomes, including epilepsy, stroke, multi |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | University of Minnesota |
| Locations | Minneapolis, Minnesota, United States |
| Start date | 2026-05-20 |
| NCT ID | NCT07517172 |
| Official listing | https://clinicaltrials.gov/study/NCT07517172 |