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

StatusRecruiting
PhaseNot applicable
SponsorTheranica
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Jan 1, 2027 → Jun 1, 2027
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Record History

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  1. Notable Enrollment increased: 40 → 100 participants
    • Primary completion pushed from Jan 1, 2027 to Jun 1, 2027
    • Study completion pushed from Jan 30, 2027 to Jul 30, 2027
    • Secondary endpoints: details revised at 4 of 6 entries
  2. Notable Enrollment target: 40 to 100 Show 5 more changesShow less
    • Study sites: 2 to 4
    • Primary completion date: Jan 1, 2027 to Jun 1, 2027
    • Study completion date: Jan 30, 2027 to Jul 30, 2027
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (6)
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
5 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07639944
Lead Sponsor Theranica
Conditions
(from sponsor)
Temporomandibular Disorder, Orofacial Pain
Related terms Facial Pain, Headache, Temporomandibular Joint Disorders
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov