Actively Recruiting
Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study
Led by University of Minnesota · Updated on 2026-05-29
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Transcutaneous Auricular Neurostimulation (tAN) as a noninvasive treatment for chronic Temporomandibular Disorders (TMD). This randomized, double-blind, sham-controlled feasibility trial aims to assess how acceptable and effective daily home-based tAN sessions are in reducing chronic orofacial pain and improving cognitive and psychosocial functions in adults with TMD. The study will enroll about 40 participants and is designed to gather crucial data to support future larger trials. Participants will be assigned to either an active tAN group or a sham stimulation group. After initial assessments, they will be trained to self-administer the assigned treatment at home daily for at least two hours, with a maximum of 24 hours. The active tAN delivers mild electrical pulses to the auricular branch of the vagus nerve via electrodes on the ear, while the sham device mimics the experience without delivering electrical stimulation. Device usage, adherence, and side effects will be tracked through internal logs. Throughout the study, participants will be monitored for retention, adherence, and acceptability of the intervention at specific time points (weeks 4 and 6). Secondary measures include evaluating pain intensity, cognitive flexibility, and mood using validated scales and wearable smartwatch data. Participants will complete surveys and check-ins electronically, with all data collected to inform the potential of tAN as a non-pharmacological option for managing TMD pain.
CONDITIONS
Brief 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 (tAN) at home and follow study procedures
- Fluency in English to understand study materials and assessments
- Access to a smartphone or computer with internet to complete electronic surveys and check-ins
You will not qualify if you...
- Neurological conditions like 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 thoughts
- Pregnancy or plans to become pregnant during the study
- Skin conditions or other issues preventing safe electrode placement on the ear
- History of trauma or surgery near the ear affecting nerve function
- Use of surgical or non-surgical bone conduction hearing devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants are trained to self-administer transcutaneous auricular neurostimulation (tAN) or sham stimulation at home daily for a minimum of two hours, with usage monitored via device logs.
Daily self-administration at home monitored remotely
Duration - 2 weeks
Participants complete assessments on retention, adherence, and acceptability of the intervention.
Electronic surveys and check-ins using smartphone or computer
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
C
Carla Campbell
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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