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Feasibility Study for Noninvasive Brain Stimulation for TMD Pain

This study is testing a new way to help people with Temporomandibular Disorder (TMD) pain. It uses Transcutaneous Auricular Neurostimulation (tAN), which is a device that sends mild electrical pulses to a nerve in your ear. Researchers want to see if this at-home treatment can reduce chronic face pain and improve related issues like mood. About 40 adults, aged 18-65, with a TMD diagnosis and pain intensity of at least 4 out of 10 for at least three months, can join. The main goals are to see if people will stick with the treatment and find it acceptable. The study status is currently unclear.

Study design
This is a randomized, double-blind study with about 40 participants. This means some participants will receive the active tAN device, and others will receive a sham (inactive) device, without knowing which one they have.
What's involved
Participants will use the tAN device daily at home. The study will track how well participants stick to the treatment for 4 weeks and how many stay in the study for 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will track participant retention for 6 weeks and adherence for 4 weeks.

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NCT07517172

Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study

Recruiting
NAAges 18–65InterventionalTreatment
University of Minnesota
~40 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Transcutaneous Auricular NeurostimulationSham Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Retention Rate
Measured over Week 6
+2 more outcomes measured

Conditions

Temporomandibular Disorder

Explore related trials

Temporomandibular Joint Disorder

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Donald Nixdorf, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Carla Campbell
[email protected]
612-625-6976
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Retention RateWeek 6

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

  • Intervention AdherenceWeek 4

    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.

  • AcceptabilityWeek 4

    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.