Nerivio Treatment for TMJ Disorder
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants report their symptoms daily via an electronic app diary with no intervention
Treatment
Eligible participants perform once daily treatments using the Nerivio Infinity device and continue to report symptoms daily via the app
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Nerivio, a Remote electrical neuromodulation (REN) device. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application. Treatment regime - once a day
Find a Clinic Near You
Who Is Running the Clinical Trial?
Theranica
Lead Sponsor
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