Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study
University of Minnesota
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 in…
Interventions
- DeviceTranscutaneous 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.
- DeviceSham 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.
Location
- University of MinnesotaMinneapolis, Minnesota