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Clinical Trial

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

NCT: NCT07639944 · RECRUITING

NCT IDNCT07639944
StatusRECRUITING
Start Date2026-05-04
Completion2027-01-30
SponsorTheranica (INDUSTRY)
First posted
Last updated

Brief 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.

Frequently Asked Questions

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

An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders is a clinical trial registered under NCT07639944. Current status: RECRUITING.

What is the status of NCT07639944?

The current status of NCT07639944 (An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders) is: RECRUITING.

When did An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders start?

An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders started on 2026-05-04.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.