40 Participants NeededMy employer runs this trial

Nerivio Treatment for TMJ Disorder

Recruiting at 1 trial location
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?

Temporomandibular disorders (TMD) encompass a group of conditions involving the masticatory muscles, temporomandibular joint (TMJ), and associated structures. TMD is the most common cause of non-odontogenic orofacial pain and is the second most commonly occurring musculoskeletal condition. Up to 70% of the general population experiences signs and/or symptoms of TMD, with headache presenting as one of the most common manifestations. Recent studies highlight the comorbid presence of headache and TMD, hypothesizing that a relationship likely exists between the two conditions. Headache severity has also been associated with the number of TMD symptoms such that the prevalence of headache in TMD patients. A key mechanism underlying both TMD and migraine is the deficiency in Conditioned Pain Modulation (CPM), a descending inhibitory pathway that regulates pain processing. CPM impairment has been implicated in chronic pain states, including both migraine and TMD, contributing to their frequent co-occurrence and shared pathophysiology.

Remote Electrical Neuromodulation (REN) is an emerging non-pharmacological intervention that exerts its analgesic effects by activating the CPM system, which is deficient in individuals with TMD and migraine. The Nerivio REN wearable device is FDA-cleared for acute and/or migraine prevention, in patients 8 years of age or older. Given the evidence linking CPM dysfunction to TMD pathogenesis, REN presents a promising therapeutic approach to addressing both the underlying pain dysregulation and symptom burden in affected patients.

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+