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Transcutaneous Auricular Neurostimulation for TMD

CC
Overseen ByCarla Campbell
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called Transcutaneous Auricular Neurostimulation (tAN) to help individuals with Temporomandibular Disorders (TMD), which cause jaw pain and discomfort. The researchers aim to determine if daily, home-based tAN sessions, which send gentle electrical pulses to the ear, can reduce pain and improve mood and cognition. Participants will receive either real stimulation or a placebo that feels similar but is inactive. This trial suits those who have experienced TMD pain for at least three months and are open to trying this non-invasive treatment at home. As an unphased trial, it offers a unique opportunity to explore a novel, non-invasive treatment option for TMD pain relief at home.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that this neurostimulation technique is safe for individuals with TMD?

Research has shown that transcutaneous auricular neurostimulation (tAN) is a safe and practical treatment for various pain conditions. This method sends gentle electrical pulses to the vagus nerve through the ear. It is non-invasive, requiring no surgery, and is usually well-tolerated. Participants in past studies reported only minor side effects, making it a promising option for those with chronic pain.

These findings come from studies not directly related to the current trial but suggest that the treatment is generally safe. For those considering joining a trial involving tAN, this information may provide reassurance about its safety.12345

Why are researchers excited about this trial?

Most treatments for temporomandibular disorder (TMD) involve pain relief through medications like NSAIDs, muscle relaxants, or corticosteroids, and sometimes physical therapy or surgery. But transcutaneous auricular neurostimulation (tAN) offers something different. It uses a non-invasive device that delivers gentle electrical stimulation to the ear, potentially reducing pain and improving function without the need for drugs. Researchers are excited about tAN because it taps into the body's natural pathways to modulate pain, offering a new, drug-free approach that patients can manage at home. This could mean fewer side effects and a more convenient treatment option for those suffering from TMD.

What evidence suggests that Transcutaneous Auricular Neurostimulation is effective for Temporomandibular Disorders?

Research suggests that transcutaneous auricular neurostimulation (tAN) might help with conditions like temporomandibular disorders (TMD), which affect the jaw. Although direct proof of tAN's effectiveness for TMD is not yet available, similar methods have shown promise in easing pain and improving symptoms in related conditions. For example, other types of nerve stimulation have successfully reduced face and jaw pain and muscle soreness. In this trial, participants will join either an active tAN group or a sham stimulation group. tAN sends gentle electrical pulses to the vagus nerve, which can help manage pain and boost mood. This non-invasive method, which does not involve surgery or needles, offers an appealing alternative to traditional treatments.23567

Who Is on the Research Team?

DN

Donald Nixdorf, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have had chronic jaw pain from temporomandibular disorder (TMD) for at least three months, with moderate or worse pain. Participants must be able to use a smartphone or computer, speak English, and be willing to do daily home treatments.

Inclusion Criteria

I have had pain rated 4 or higher out of 10 in the past two weeks.
I have had jaw pain for at least three months.
I am between 18 and 65 years old.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily, home-based Transcutaneous Auricular Neurostimulation (tAN) sessions for Temporomandibular Disorders (TMD)

6 weeks
Home-based sessions with device log tracking

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Auricular Neurostimulation

Trial Overview

The study tests whether daily home-based transcutaneous auricular neurostimulation (tAN)—a device that sends mild electrical pulses to the ear—can help reduce TMD-related facial pain. Some participants will get real stimulation; others will receive sham (inactive) treatment. The trial is randomized and double-blind.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active tANActive Control1 Intervention
Group II: Sham StimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Citations

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The results of the studies revealed a positive effects for the complex treatment dysfunctions syndrome TMJ the using the patches by the company “Aganyan”

Transcutaneous Auricular Vagus Nerve Stimulation for the ...

However, no evidence about taVNS effectiveness in patients with chronic pain associated with temporomandibular disorders (TMD) is available.

Transcutaneous Auricular Neurostimulation for TMD

The study monitors feasibility through retention and adherence rates while tracking secondary outcomes such as pain intensity, cognitive ...

NCT05500716 | The Effect of Vagus Nerve Stimulation on ...

In a study, it was observed that HRV, which is a marker of ANS dysfunction, decreased in patients with myofascial temporomandibular disorder (TMD) compared to ...

A Randomised Controlled Trial

The beneficial effects of LLLT on pain relief and tissue healing observed in our study are consistent with prior research demonstrating similar ...

Transcutaneous auricular vagus nerve stimulation for ... - PMC

This is the first clinical trial to assess the feasibility of taVNS in patients with chronic TMD symptoms.

Transcutaneous Auricular Vagus Nerve Stimulation for ... - PMC

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and feasible treatment for a variety of acute and chronic pain conditions.