Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.

March 13, 2026 updated by: Arpana Church

Pilot Study of the Effects of Transcutaneous Non-Invasive Vagus Nerve Stimulation (nVNS) on Symptoms and Brain Mechanisms in Premenopausal Women With Temporomandibular Disorders (TMD)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 diseases and congenital or developmental disorders.
  • Pathologic processes found on imaging including neoplasm (Exception: disc displacements and osseous pathology including osteoarthritis/osteoarthrosis).
  • Radiation treatment to head and neck
  • Prior jaw or open TMJ (including contralateral joint) surgery including plication, chondroplasty, joint replacement, disectomy, and discoplasty.
  • Intra-articular therapies of TMJ being sampled that include arthrocentesis, visco-supplementation, and steroid, platelet-rich plasma/platelet-rich fibrin administration within the last 6mo
  • Recent febrile illness within the past 8 weeks that precludes or delays participation by more than 90 days
  • Trauma to jaw in the last 2mo
  • Presence of non-TMD orofacial pain disorders excluding comorbidity of interest (fibromyalgia).
  • Pregnancy or lactation
  • Undergoing or previously undergone bone anabolic or other hormonal therapies for medical needs
  • Unable to participate due to language barrier or mental/intellectual incompetence
  • Use of antidepressant drugs unless the participants have been on a stable dose for 60 days.
  • Drug and/or alcohol abuse in the past year
  • Ongoing dental treatments requiring invasive procedures (e.g. implant placement, tooth extractions, etc.)
  • Recent dental treatments within past two weeks that required sustained mouth opening for more than 20 minutes.
  • Wearing removable or implant supported dentures or fixed orthodontic appliances
  • Unable or unwilling to give informed consent
  • Participation in another clinical study that interferes with participation in this study
  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
  • Presence of non-TMD orofacial pain disorders such as that from periodontal disease and carious lesions.
  • Presence of major psychiatric diagnosis such as schizophrenia, bipolar disorder, post-traumatic stress disorder, obsessive compulsive disorder, or current history of drug or alcohol abuse.
  • Individuals with current regular use of narcotics and/or opioids. Use of centrally acting medications that will interfere with neuroimaging testing, such as systemic steroids, opiate analgesics.
  • Smokes/Vapes tobacco more than 1/3 pack per day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active nVNS Treatment
nVNS Treatment 2x/week for 8 weeks
Device: nVNS Treatment
nVNS treatment 2x/week for 8 consecutive weeks.
Other Names:
  • vagus nerve stimulation
  • non-invasive vagus nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
To be measured using a numeric rating scale 0-10.
From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
Pain Unpleasantness
Time Frame: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
To be measured using a visual analog scale.
From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
Positive and Negative Affect
Time Frame: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
To be measured using the positive and negative affect scale (PANAS).
From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arpana Church

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 25-0801

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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