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Recruiting NCT07517172

Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study

No phase Interventional Temporomandibular Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Auricular Neurostimulation, Sham Stimulation.
Who it may be relevant to
Registry conditions: Temporomandibular Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Primary outcome measures

  • Retention Rate [Time frame: Week 6]
  • Intervention Adherence [Time frame: Week 4]
  • Acceptability [Time frame: Week 4]

Eligibility criteria

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, multiple sclerosis, or traumatic brain injury.
  • Use of implanted neuromodulation devices, such as vagus nerve stimulators, deep brain stimulators, or cochlear implants.
  • Unstable or severe psychiatric disorders, including active psychosis or severe depression with suicidal ideation.
  • Pregnancy or intention to become pregnant during the study period.
  • Skin conditions or other contraindications that prevent safe electrode placement on the auricular region (e.g., metal in the cymba concha that is unable or not willing to remove).
  • History of trauma (e.g., skull fracture) or periauricular surgery (e.g., temporomandibular joint replacement, acoustic neuroma removal) which would affect the location and function of the target peripheral innervation.
  • Use of both surgical and non-surgical bone conduction hearing devices.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07517172 · DENT-2025-34560

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗