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NCT07639944 · ClinicalTrials.gov registry record · NA
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
A NA study, sponsored by Theranica.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT07639944: Recruiting NA study, sponsored by Theranica.
NCT07639944 is a NA study that is actively recruiting participants, run by Theranica. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07639944, a NA study, is actively recruiting participants, sponsored by Theranica.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
The change in daily maximum-pain level (on the numeric rating scale, NRS, of 0-10) as measured by comparing the average daily maximum orofacial-pain score in the last 2 weeks of baseline phase (weeks 3-4) to the last 2 weeks of the intervention phase (weeks 9-10). Pain score will be taken from any of the orofacial locations specified in the daily diary (jaw, head, neck, ear, eye, face, teeth) that presented the maximum daily pain. Patients will log their maximum pain levels in a daily diary, thr
Interventions
- DEVICE Nerivio treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-05-04 |
| Est. Completion | 2027-01-30 |
| Phase | NA |
What NCT07639944 shows while recruiting
NCT07639944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Nerivio treatment is the first listed.
NCT07639944 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07639944 about?
NCT07639944 is a clinical study titled "An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders". 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%...
What is the current status of trial NCT07639944?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2026-05-04. Estimated completion is 2027-01-30.
What interventions are being tested in trial NCT07639944?
The interventions under investigation include: Nerivio treatment (DEVICE).
Who is sponsoring clinical trial NCT07639944?
This trial is sponsored by Theranica, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07639944's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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