TMDNCT07288411
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
A study testing nVNS Treatment in people with TMD and Temporomandibular Disorders (TMDs), run by Arpana Church at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- TMD, Temporomandibular Disorders (TMDs)
- What is being tested?
- nVNS Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: 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.
- Conditions
- TMD, Temporomandibular Disorders (TMDs)
- Being tested
- nVNS Treatment
- Keywords
- TMD, Temporomandibular Disorders, non-invasive vagus nerve stimulation, nVNS
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nVNS TreatmentDevice
Also called vagus nerve stimulation, non-invasive vagus nerve stimulation
nVNS treatment 2x/week for 8 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active nVNS Treatment | Experimental | nVNS Treatment 2x/week for 8 weeks Receives: Device: nVNS Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
To be measured using a numeric rating scale 0-10.
Measured: 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.
Measured: 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).
Measured: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study startDec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot/Feasibility, Pre/Post Intervention Study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arpana Church
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arpana Church, University of California, Los Angeles
- Investigators
- Arpana Church, Ph.D., Principal investigator, The Regents of the University of California, Los AngelesSunil Kapila, B.D.S., M.S., Ph.D., Principal investigator, The Regents of the University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288411
- Sponsor's protocol ID
- IRB 25-0801
- Status last verified
- Nov 2026
- First submitted
- 5 Dec 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07288411
- Acronym / sponsor ID
- IRB 25-0801
- Conditions
- TMD, Temporomandibular Disorders (TMDs)
- Keywords
- TMD, Temporomandibular Disorders, non-invasive vagus nerve stimulation, nVNS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Arpana ChurchUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot/Feasibility, Pre/Post Intervention Study
| Arm | Type | Receives |
|---|---|---|
| Active nVNS Treatment | Experimental | Device: nVNS TreatmentnVNS Treatment 2x/week for 8 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nVNS TreatmentAlso: vagus nerve stimulation, non-invasive vagus nerve stimulationnVNS treatment 2x/week for 8 consecutive weeks. | Device | Active nVNS Treatment |
Primary outcome
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.
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nVNS Treatment in people with TMD and Temporomandibular Disorders (TMDs), run by Arpana Church at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Vaughan, MPH (3108257206, ChurchLab@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: From the baseline in-clinic visit through 8 weeks of biweekly visits, assessed immediately before and after each nVNS session.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.