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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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Is of 12 years of age and older (inclusive; of any gender, race, or ethnicity)

• Meets diagnostic criteria for chronic TMD (Myalgia and/or Arthralgia) based on the Diagnostic Criteria for TMD (DC/TMD)

• Has experienced TMD pain for at least 6 months

• Has experienced TMD pain at level ≥4 on a 0-10 scale for at least 10 days of the last 30 days

• Commits to not making any changes to TMD treatment regime (medication and/or non-medication), including not adding or removing treatment, and if on any existing treatment then maintaining the same treatment type, dosage, and frequency from 3 months prior to enrollment to study completion

• Naïve to REN treatment

• Willing and able to understand and comply with all study procedures and be available for the duration of the study

• Has their own smartphone or tablet device that is connected to the internet

• Provides a signed and dated informed consent form

Locations
United States
Mississippi
Proven Endpoints
RECRUITING
Ridgeland
New York
True North neurology
RECRUITING
Commack
Contact Information
Primary
Dagan Harris, PhD
daganh@theranica.com
+972542220121
Time Frame
Start Date: 2026-05-04
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 40
Treatments
Experimental: Nerivio 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
Related Therapeutic Areas
Sponsors
Leads: Theranica

This content was sourced from clinicaltrials.gov