Daily ear vagus‑nerve stimulation to reduce TMD jaw and facial pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Donald Nixdorf, MD — University of Minnesota
• Study coordinator: Carla Campbell
• Email: ohcrc@umn.edu
• Phone: 612-625-6976

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Botulinum toxin for jaw myofascial pain in adults

  This study tests whether injecting botulinum toxin into jaw muscles helps reduce pain and improve mouth opening in adults with stubborn temporomandibular myofascial pain.

  Recruiting Phase 2 Riphah International University · Islamabad · NCT07847541

• What predicts how bad TMD is, involving jaw, neck, and posture

  We will test if jaw dysfunction, neck position sense, and head/neck posture relate to how severe temporomandibular disorders are in adults.

  Recruiting Ankara Yildirim Beyazıt University · Ankara · NCT07666360

• Nerivio in adults and adolescents with chronic TMD headache

  This study tests a Nerivio device to help people 12 and older with chronic temporomandibular disorder and headaches see if the treatment reduces pain.

  Recruiting at 4 sites Theranica · Newark, Delaware and 3 other locations · NCT07639944

• Heat therapy for jaw pain in chronic TMD

  This study tests whether applying local heat to the jaw can reduce pain and jaw fatigue in adults with chronic temporomandibular disorder during a clenching task.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT07153107

• Using Botulinumtoxin A to treat pain in jaw disorders

  This study is testing if Botulinumtoxin A injections can help reduce pain and improve life for people with jaw disorders caused by muscle issues.

  Recruiting Phase 3 Region Stockholm · Stockholm · NCT06941636

• Investigating the link between levonorgestrel intrauterine system and temporomandibular disorders

  This study is trying to see if using a specific birth control device called the levonorgestrel intrauterine system is linked to jaw joint problems in women.

  Recruiting Marmara University · Istanbul, Maltepe · NCT06500390

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.