100 Participants NeededMy employer runs this trial

Nerivio Treatment for TMJ Disorder

Recruiting at 3 trial locations
DH
Overseen ByDagan Harris, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Theranica
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 explores a new treatment for temporomandibular disorder (TMD), a common cause of jaw and face pain often linked to headaches. The treatment uses a device called Nerivio, which sends small electrical pulses to the arm to reduce pain by activating the body's natural pain control system. The trial seeks participants who have experienced TMD pain for at least 6 months and have significant pain on most days. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to new pain management solutions.

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

You must keep your current TMD treatment the same, including medication type, dosage, and frequency, from 3 months before joining the study until it ends. If you're taking more than one prescription drug for pain, you may not be eligible to participate.

What prior data suggests that the Nerivio device is safe for treating TMJ disorder?

Research has shown that the Nerivio device, which employs Remote Electrical Neuromodulation (REN), is generally safe for treating migraines. In large studies, only 0.5% of users experienced mild side effects. The FDA has approved the device for individuals as young as 8 years old. However, individuals with certain conditions, such as uncontrolled epilepsy or specific implanted medical devices like pacemakers, should not use Nerivio. Overall, evidence suggests that Nerivio is well-tolerated for its intended use.12345

Why are researchers excited about this trial?

Most treatments for TMJ disorder involve medications, physical therapy, or even surgery. But Nerivio offers something different. It's a wearable device that uses remote electrical neuromodulation (REN) to stimulate nerves in the upper arm, triggering the body's natural pain-relief mechanisms without drugs. This method is non-invasive and controlled via a smartphone app, making it convenient for self-administration. Researchers are excited because it could offer a drug-free, user-friendly alternative to traditional treatments.

What evidence suggests that the Nerivio device is effective for TMJ disorder?

Research has shown that the Nerivio device can help manage pain through Remote Electrical Neuromodulation (REN). This method activates the body's natural pain control system, which often functions poorly in individuals with jaw disorders and migraines. The FDA has already approved the Nerivio device for treating migraines in people aged 8 and older. In this trial, participants will use the Nerivio device to stimulate the upper arm, potentially reducing pain and symptoms related to jaw disorders. This offers a promising non-drug treatment for jaw pain and headaches.678910

Who Is on the Research Team?

AS

Alit Stark Inbar, PhD

Principal Investigator

Theranica

Are You a Good Fit for This Trial?

This trial is for people aged 12 and older who have had chronic temporomandibular joint disorder (TMD) pain for at least 6 months, with moderate or worse pain on at least 10 days in the last month. Participants must not have used REN before, must keep their current TMD treatments unchanged, and need to use a smartphone or tablet.

Inclusion Criteria

I have had moderate to severe jaw pain for at least 10 days in the past month.
I am 12 years old or older.
I have been diagnosed with chronic TMD (myalgia and/or arthralgia).
See 6 more

Exclusion Criteria

I have been diagnosed with migraine, with or without aura.
I have taken opioid medication in the past 30 days.
I have taken an experimental drug or treatment in the last 30 days.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants report their symptoms daily via an electronic app diary with no intervention

4 weeks
Daily symptom reporting via app

Treatment

Eligible participants perform once daily treatments using the Nerivio Infinity device and continue to report symptoms daily via the app

6 weeks
Daily treatment and symptom reporting via app

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nerivio treatment

Trial Overview

The study tests the Nerivio wearable device, which uses remote electrical neuromodulation (REN), to see if it helps manage headaches related to TMD. The device is worn on the arm and controlled by an app. All participants will receive this treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Nerivio treatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Theranica

Lead Sponsor

Trials
21
Recruited
41,700+

Citations

TMJ disorders - Symptoms and causes

TMJ disorders — a type of temporomandibular disorder or TMD — can cause pain in the jaw joint and in the muscles that control jaw movement.

TMD (Temporomandibular Disorders) - NIDCR - NIH

There is limited evidence that it helps TMDs.17,18 TENS is a battery-powered device … some studies have shown that TENS may help relieve pain in TMDs and ...

3.

tmj.org

tmj.org/

The TMJ Association: Empowering You With The Truth

For many, the symptoms go away on their own after a period of time are safe and effective.

What causes TMJ pain and what can I do about it?

The TMJ allows the jaw to open and close smoothly for daily functions. When this system is disrupted, it can lead to pain and discomfort.

TMJ Disorders: Symptoms & Treatment

TMD causes jaw pain, headaches and trouble chewing. It's common and treatable with therapies that ease pain and improve jaw function.

New Study Demonstrates Consistent Positive Long-Term ...

The company's award-winning flagship wearable, Nerivio®, is an FDA-cleared and CE-marked prescription device for complete care of migraine - ...

Nerivio® Clinical Trials

Nerivio should not be used by people with uncontrolled epilepsy, an active implantable medical device, such as a pacemaker, hearing aid implant or any implanted ...

A Prospective Post-marketing Observational Study ...

The study will assess the safety and efficacy of Nerivio, used every other day for prevention and possibly whenever needed for acute treatment,

Largescale Real-World Migraine Study Solidifies Efficacy ...

In terms of safety, only 0.5% of all patients experienced any kind of adverse event, and all adverse events were categorized as mild, non- ...

Device profile of the Nerivio for acute migraine treatment

Nerivio has been studied in two randomized trials which provide support for the efficacy and safety of the device.