Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.

NCT ID: NCT07288411

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active nVNS Treatment

nVNS Treatment 2x/week for 8 weeks

Group Type: EXPERIMENTAL

nVNS Treatment

Intervention Type: DEVICE

nVNS treatment 2x/week for 8 consecutive weeks.

Interventions

nVNS Treatment

nVNS treatment 2x/week for 8 consecutive weeks.

Intervention Type: DEVICE

Other Intervention Names

vagus nerve stimulation; non-invasive vagus nerve stimulation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Arpana Church

OTHER

Sponsor Role: lead

Responsible Party

Arpana Church

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

IRB 25-0801

Identifier Type: -

Identifier Source: org_study_id