Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study

NCT07517172 | Recruiting

• 1 other identifier: DENT-2025-34560
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Temporomandibular Disorder

Outcome Measures

Primary Outcomes (3)

• Retention Rate

  The proportion of enrolled participants who complete both baseline and post-treatment assessments. A retention rate of ≥50% is considered feasible.

  Week 6

• Intervention Adherence

  The percentage of prescribed tAN sessions completed by each participant, as recorded in the internal device log. Feasibility is defined as ≥50% adherence to scheduled sessions.

  Week 4

• Acceptability

  Measured using a post-treatment Likert scale survey, where participants will rate comfort, usability, and willingness to use tAN again on a 1 to 5 scale. A mean acceptability score of ≥3/5 indicates feasibility.

  Week 4

Study Arms (2)

Active tAN

ACTIVE COMPARATOR

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.

Device: Transcutaneous Auricular Neurostimulation

Sham Stimulation

PLACEBO COMPARATOR

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.

Device: Sham Stimulation

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.

Active tAN

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.

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Donald Nixdorf, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Campbell

CONTACT

612-625-6976; ohcrc@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The purpose of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of Transcutaneous Auricular Neurostimulation (tAN) as a noninvasive brain stimulation approach for reducing pain and improving cognitive function in individuals with Temporomandibular Disorders (TMD).

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: April 8, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

US (1)