Daily ear vagus‑nerve stimulation to reduce TMD jaw and facial pain
Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study
This will test whether daily, at‑home gentle electrical stimulation of the ear's vagus nerve can reduce chronic jaw and facial pain in adults with temporomandibular disorder (TMD).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT07517172 on ClinicalTrials.gov |
What this trial studies
This randomized, double‑blind, sham‑controlled feasibility trial will enroll about 40 adults with chronic TMD to try daily transcutaneous auricular neurostimulation (tAN) at home. Participants will be randomly assigned to active or sham stimulation and will self‑administer mild electrical pulses to the auricular branch of the vagus nerve while researchers monitor adherence and retention. The study will track changes in pain intensity, cognitive flexibility, and mood using validated questionnaires and wearable smartwatch data. Results are intended to inform whether a larger clinical trial is warranted and whether tAN could be a practical non‑pharmacologic option for people who have not responded to standard TMD treatments.
Who should consider this trial
Good fit: Adults aged 18–65 with a DC‑TMD diagnosis, at least 3 months of pain scoring ≥4/10, who can read English, have a smartphone or computer, and are willing to self‑administer daily tAN at home are ideal candidates.
Not a fit: People with certain neurological disorders (for example epilepsy, stroke, multiple sclerosis, or traumatic brain injury), implanted neuromodulation devices, unstable severe psychiatric conditions, or those unable/unwilling to self‑administer home stimulation or attend visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could offer a noninvasive, drug‑free way to lower chronic orofacial pain and improve related mood and cognitive symptoms for people with TMD.
How similar studies have performed: Early small studies of noninvasive auricular vagus stimulation have shown promising signals for pain and mood, but its use specifically for chronic TMD is still largely untested and requires larger trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Donald Nixdorf, MD — University of Minnesota
- Study coordinator: Carla Campbell
- Email: camp2757@umn.edu
- Phone: 612-625-6976
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.