Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07517172
Status
Recruiting
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Conditions

  • Temporomandibular Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Auricular Neurostimulation — DEVICE
    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.
  • Sham Stimulation — DEVICE
    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.

Study Details

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 Dates

Start date
May 20, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active tAN
    After the baseline assessments, participants will be trained to self-administer tAN at home according to their assigned condition (active or sham). They will be instructed to use the device daily for a minimum of two hours (maximum is 24 hours) while recording any side effects. The device's internal log will track session compliance, stimulation parameters, and usage frequency.
  • Placebo Comparator: 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.

Primary Outcome Measure

Retention Rate [ Time Frame: Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Carla Campbell
[email protected]
612-625-6976

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By research site
University of Minnesota· Minneapolis, MN

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