RecruitingNot ApplicableNCT07639944

An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders

An Open Label, Single-arm Multicenter Study Assessing the Safety and Efficacy of Remote Electrical Neuromodulation (Ren) in the Management of Headache, Orofacial Pain, and Other Symptoms Attributed to Temporomandibular Disorders (TMD)


Sponsor

Theranica

Enrollment

40 participants

Start Date

May 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Nerivio treatment for people with temporomandibular disorder. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENerivio 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.


Locations(2)

Proven Endpoints

Ridgeland, Mississippi, United States

True North neurology

Commack, New York, United States

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NCT07639944


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