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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)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Allison Vaughan, MPH
ChurchLab@mednet.ucla.edu
3108257206
Time Frame
Start Date: 2026-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 10
Treatments
Experimental: Active nVNS Treatment
nVNS Treatment 2x/week for 8 weeks
Related Therapeutic Areas
Sponsors
Leads: Arpana Church

This content was sourced from clinicaltrials.gov