Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.

NCT07288411 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB 25-0801
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

TMD; Temporomandibular Disorders (TMDs)

Keywords

TMD; Temporomandibular Disorders; non-invasive vagus nerve stimulation; nVNS

Outcome Measures

Primary Outcomes (3)

• Pain Intensity

  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

  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

  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.

Study Arms (1)

Active nVNS Treatment

EXPERIMENTAL

nVNS Treatment 2x/week for 8 weeks

Device: nVNS Treatment

Interventions

nVNS Treatment DEVICE

nVNS treatment 2x/week for 8 consecutive weeks.

Also known as: vagus nerve stimulation, non-invasive vagus nerve stimulation

Active nVNS Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arpana Church: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pilot/Feasibility, Pre/Post Intervention Study

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 17, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03