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RecruitingNCT07288411Updated Nov 6, 2026

Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.

An interventional study of nVNS Treatment in TMD and Temporomandibular Disorders (TMDs), sponsored by Arpana Church. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Arpana Church · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • TMD
  • Temporomandibular Disorders (TMDs)

Keywords

  • TMD
  • Temporomandibular Disorders
  • non-invasive vagus nerve stimulation
  • nVNS
03

In context

Temporomandibular Joint Disorders

591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.

This study's planned enrollment of 10 is below the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

This is the only study on the registry with Arpana Church as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 include TMJ and/or masticatory and cervical muscle pain.
  • 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

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/ 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 , -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
  • 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Active nVNS Treatment

    nVNS Treatment 2x/week for 8 weeks

    Device: nVNS Treatment

Interventions

  • DevicenVNS Treatment

    nVNS treatment 2x/week for 8 consecutive weeks.

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

06

What researchers measure

Primary outcomes

  1. Pain Intensity

    To be measured using a numeric rating scale 0-10.

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

  2. Pain Unpleasantness

    To be measured using a visual analog scale.

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

  3. Positive and Negative Affect

    To be measured using the positive and negative affect scale (PANAS).

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

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Start date
Sep 1, 2026→Dec 2026
Nov 6, 2026
Primary completion
Dec 31, 2026→Dec 31, 2027
Nov 6, 2026
Study completion
Dec 31, 2026→Dec 31, 2027
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    Start date Sep 1, 2026→Dec 2026
    Primary completion Dec 31, 2026→Dec 31, 2027
    Study completion Dec 31, 2026→Dec 31, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07288411
Lead sponsor
Arpana Church
Responsible party
Arpana Church (Principal Investigator, University of California, Los Angeles) — Sponsor-investigator
First posted
Dec 17, 2025
Start date
Dec 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Allison Vaughan, MPH
Contact
ChurchLab@mednet.ucla.edu
3108257206
Arpana Church, Ph.D.
principal investigator · The Regents of the University of California, Los Angeles
Sunil Kapila, B.D.S., M.S., Ph.D.
principal investigator · The Regents of the University of California, Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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