BridgeMD
New treatment option for Temporomandibular Disorder
Official title Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study
ClinicalTrials.gov ID: NCT07517172
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- 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...
- History of trauma (e.g., skull fracture) or periauricular surgery (e.g., temporomandibular joint replacement, acoustic neuroma removal) which would...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.