Actively Recruiting
Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study
Led by University of Minnesota · Updated on 2026-05-08
40
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years.
- Diagnosis of temporomandibular disorder (TMD) based on Diagnostic Criteria for Temporomandibular Disorders (DC-TMD).
- Pain intensity of at least 4 out of 10 on the Numeric Rating Scale over the past two weeks.
- Chronic pain lasting at least three months consistent with chronic TMD.
- Willingness to self-administer transcutaneous auricular nerve stimulation at home and follow study procedures.
- Fluency in English to understand study materials and assessments.
- Access to a smartphone or computer with internet for electronic surveys and check-ins.
You will not qualify if you...
- Neurological conditions such as epilepsy, stroke, multiple sclerosis, or traumatic brain injury.
- Use of implanted neuromodulation devices like vagus nerve stimulators, deep brain stimulators, or cochlear implants.
- Unstable or severe psychiatric disorders including active psychosis or severe depression with suicidal thoughts.
- Pregnancy or planning to become pregnant during the study.
- Skin conditions or contraindications preventing safe electrode placement on the ear.
- History of trauma (e.g., skull fracture) or ear-area surgery affecting the nerve target.
- Use of surgical or non-surgical bone conduction hearing devices.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
C
Carla Campbell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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