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

Part of paid clinical trials in Ridgeland, Mississippi.

Sponsor
Theranica
Study ID
NCT07639944
Status
Recruiting
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Conditions

  • Temporomandibular Disorder

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nerivio treatment — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 4, 2026
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Jan 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in daily maximum-pain level [ Time Frame: 10 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Proven EndpointsRidgelandMississippi39157
Vanessa Case
[email protected]
601-790-1811
Kristi Trimm, MD (PRINCIPAL_INVESTIGATOR)
True North neurologyCommackNew York11725
Tiffany Harding, CCRC
[email protected]
631-364-9119
Warren Spinner,, MD (PRINCIPAL_INVESTIGATOR)

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