10 Participants NeededMy employer runs this trial

Vagus Nerve Stimulation for TMJ Disorder

AV
Overseen ByAllison Vaughan, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help premenopausal women with temporomandibular disorders (TMD), which can cause jaw pain and limited mouth opening. The treatment, called nVNS Treatment, uses a device to stimulate the vagus nerve without surgery, aiming to reduce pain by affecting brain and gut connections. Ideal participants are premenopausal women experiencing jaw pain, difficulty opening their mouths, or noise in the jaw joint. Participants must visit the clinic regularly for treatments and tests over eight weeks. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for TMD.

What prior data suggests that this non-invasive vagus nerve stimulation is safe for premenopausal women with temporomandibular disorders?

Research has shown that non-invasive vagus nerve stimulation (nVNS) is generally well-tolerated. This treatment avoids surgery or skin penetration, making it safer than invasive methods. It uses a device on the skin to stimulate the vagus nerve, aiding in pain management and other body functions.

While direct studies on its safety for temporomandibular disorders (TMD) are limited, nVNS has been studied for other chronic pain conditions with favorable safety outcomes. Participants in these studies reported very few side effects, which were usually mild. This makes nVNS a promising option for those considering a clinical trial for TMD.12345

Why are researchers excited about this trial?

Unlike the standard treatments for TMJ disorder, which often involve medications like pain relievers or muscle relaxants, physical therapy, or even surgery, the nVNS (non-invasive Vagus Nerve Stimulation) treatment offers a unique approach. This treatment is different because it targets the vagus nerve using a non-invasive device that is applied externally, potentially reducing pain and inflammation without the need for medication. Researchers are excited about nVNS because it could offer a new, drug-free option with fewer side effects for those suffering from TMJ disorder. Additionally, its non-invasive nature makes it a convenient and accessible treatment option for patients.

What evidence suggests that this nVNS treatment might be an effective treatment for TMD?

Research has shown that non-invasive vagus nerve stimulation (nVNS) may help with chronic pain. It sends gentle electrical signals to the vagus nerve, which extends from the brain, through the face, and into the abdomen. This stimulation is believed to enhance communication between the brain and the gut, potentially reducing pain. Early results suggest that nVNS could be effective for various pain conditions, although its effects on temporomandibular disorders (TMD) are still under investigation. Participants in this trial will receive the active nVNS treatment, which is non-invasive and doesn't require surgery, making it an appealing option for many.16789

Who Is on the Research Team?

AC

Arpana Church, Ph.D.

Principal Investigator

The Regents of the University of California, Los Angeles

SK

Sunil Kapila, B.D.S., M.S., Ph.D.

Principal Investigator

The Regents of the University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for right-handed, premenopausal women ages 18-50 who have TMJ disorder symptoms like jaw pain, limited mouth opening, or joint noise. Participants must not be pregnant and need to speak English fluently.

Inclusion Criteria

I have jaw, chewing muscle, or neck muscle pain found during screening.
I am between 18 and 50 years old.
Must have a negative urine test for pregnancy
See 4 more

Exclusion Criteria

I have had surgery on my jaw or TMJ in the past.
I have received TMJ joint injections or treatments in the past 6 months.
Pregnancy or lactation
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nVNS treatment 2x/week for 8 weeks, with in-clinic visits at baseline and post-treatment including physical measures, blood draw, saliva sample, and brain MRI

8 weeks
2 in-clinic visits, 16 treatment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • nVNS Treatment

Trial Overview

The study tests non-invasive vagus nerve stimulation (nVNS) as a treatment for TMJ disorder. Participants receive nVNS twice weekly for 8 weeks, with clinic visits before and after treatment to assess changes in symptoms and brain activity.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Active nVNS TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arpana Church

Lead Sponsor

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