Not Yet RecruitingNot Applicable

Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.

10 participantsStarted 2026-06-01

Plain-language summary

The study aims to examine the effects of transcutaneous non-invasive vagus nerve stimulation (nVNS) on symptoms and brain mechanisms in premenopausal women with temporomandibular disorders (TMD). Non-invasive vagus nerve stimulation (nVNS) is the most well researched and possibly the most effective non-invasive neuromodulation treatment for chronic pain conditions that targets the brain-gut-microbiome (BGM) axis. Participants will be asked to come in for 2 in-clinic visits, at baseline and post treatment. Participants will also be asked to come in 2x/week for 8 consecutive weeks to receive the nVNS treatment. The in-clinic visits will include physical measures, blood draw, saliva sample, and brain MRI. Participants will be asked to collect a stool sample at home and answer online questionnaires regarding, mood, pain, and health behaviors at home, prior to the in-clinic appointments.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ages 18-50 * Premenopausal menstruating women\* * Participants report or present with at least 1 of 3 cardinal signs of TMD: jaw pain, limited mouth opening, or TMJ noise. * Specific screening reveals clinical findings that require standard of care medically-indicated intra-articular procedure for management of symptoms including TMJ pain, intra-articular joint disorder leading to joint locking or limited mouth opening or displacement, and severe degenerative joint disease. * Must have a negative urine test for pregnancy * Ability to speak the English language fluently due to the standardized assessments involved * Right-handed (participants are limited to right-handed individuals to reduce variability in brain lateralization and ensure more consistent, interpretable data). * Only premenopausal women are included to control for hormonal variability that may influence the results. Participants will be scheduled during their follicular phase based on self-reported last menstrual period to further reduce hormonal confounds. Exclusion Criteria: * Medical condition, laboratory finding, or physical exam finding that precludes participation, such as systemic arthritides, juvenile idiopathic arthritis, idiopathic condylar resorption, connective tissue disorders, mandibular osteonecrosis, mandibular and condylar fractures, salivary gland disorders (incl. history of stones or swelling), neoplasms, neurologic/neuropathic, endocrine, or immune/autoimmune disea…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Intensity

Timeframe: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.

Pain Unpleasantness

Timeframe: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.

Positive and Negative Affect

Timeframe: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.

Trial details

NCT IDNCT07288411

SponsorArpana Church

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More TMD trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pain Intensity

Timeframe: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.

Pain Unpleasantness

Timeframe: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.

Positive and Negative Affect

Timeframe: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.