An interventional study of Nerivio treatment in Temporomandibular Disorder and Orofacial Pain, sponsored by Theranica. Recruiting at 4 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Theranica · Not applicable, Interventional, and Treatment
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.
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. Accordingly, a recent systematic review and meta-analysis supported a positive association between pain-related TMD, migraine, and chronic tension-type headaches. Other studies demonstrated that, among patients seeking care for headaches, the prevalence of those presenting with TMD symptoms ranged from 52-55%. Headache severity has also been associated with the number of TMD symptoms such that the prevalence of headache in TMD patients with one TMD symptom was 57%, with two symptoms was 65%, and with three or more symptoms was 73%. Notably, the Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA) study -the largest population-based study in adults designed to identify risk factors associated with the onset and persistence of TMD - showed that prior headaches were a significant risk factor for the development of first-onset TMD symptoms9. After the development of TMD, both headache severity and frequency were shown to increase in the TMD group compared to healthy participants. Specifically, the prevalence of migraine episodes increased 10-fold in the group that developed TMD symptoms. Finally, clinical studies revealed that, when TMD is successfully treated, headache symptoms also tend to resolve, suggesting a role of TMD in the pathophysiological process.
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. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment. By enhancing endogenous pain inhibition, REN has been shown to provide effective relief in migraine, and its application in TMD is expected to yield similar clinical benefits. 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.
The aim of this study is to evaluate the safety and efficacy of Nerivio Infinity for the management of headache, orofacial pain and TMD related symptoms.
This is an open-label, single arm study to determine whether REN can be utilized for the management of TMD-related pain and other symptoms. 40 participants (ages 12 years and older) with a TMD diagnosis will be enrolled. Treatment will be performed once daily for 45 minutes per treatment, for 6 weeks. Daily treatment ensures consistent neuromodulation, is expected to reduce overall pain severity, and to maintain CPM activation. TMD pathophysiology supports daily use: TMD involves central sensitization and chronic engagement of the trigeminal system, similar to migraine. Unlike migraine, where individual attacks may be separated by pain-free periods, TMD pain is often persistent or recurrent on a near-daily basis. Moreover, daily use ensures sustained neuromodulatory effects to prevent worsening of pain flares while improving functional jaw mobility. Daily use is expected to reduce overall pain severity, attack frequency, and functional impairment (aligning with migraine prevention goals). Additional acute use (as-needed adjunct to daily treatment) will be permitted and is expected to address pain flare-ups that may still occur despite daily neuromodulation.
The study will consist of two main phases:
4-week baseline phase- in which participants will report their symptoms daily via an electronic app diary (with no intervention); 6-week intervention phase- in which eligible participants perform once daily treatments using Nerivio Infinity device, and continue to report symptoms daily via the app.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Theranica is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Has any of the following medical conditions:
1.1 Uncontrolled seizures/epilepsy 1.2 Benign and malignant TMJ and masticatory muscle tumors 1.3 Presence of implanted electrical device
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: 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.
Change in daily maximum-pain level
The change in daily maximum orofacial pain level, by comparing the average daily maximum-pain level in the 4 weeks of the baseline phase (weeks 1-4) to the last 4 weeks of the intervention phase (weeks 7-10), measured by Numeric Rating Scale score (NRS, 0-10). Pain level will be taken from any of the orofacial locations specified in the daily diary (jaw, head, neck, ear, eye, face, teeth), as reported in a daily diary, through a study specific smartphone application. Numeric Rating Scale score is on a scale of 0 (no pain) to 10 (worst pain),
Time frame: 10 weeks
Change in self-reported Jaw Functional Limitation Scale (JFLS)
Change in the self-reported Jaw Functional Limitation Scale (JFLS, 0-10) from the end of the baseline phase (visit 2) to following the intervention phase at week 10 (visit 3) to compare post-treatment changes in limitations of jaw function. Jaw Functional Limitation Scale score is from 0 (no limitation) to 10 (severe limitation).
Time frame: 10 weeks
Change in number of days with orofacial pain
Change in number of days with any orofacial pain, comparing the 4 weeks of the baseline phase (weeks 1-4) to the last 4 weeks of the intervention phase (weeks 7-10).
Time frame: 10 weeks
Change in Patient Global Impression of Change (PGIC) scores
Compare average Patient Global Impression of Change (PGIC) scores regarding orofacial pain following the intervention at visit 3, to assess if patients perceive greater improvement with using REN. Patient Global Impression of Change score is from 1 (very much improved) to 7 (Very much worse).
Time frame: 10 weeks
Responder rate of at least 30% reduction in daily maximum-pain level
Proportion of patients showing \>30% reduction in average daily maximum-pain level, by comparing the 4 weeks of the baseline phase (weeks 1-4) to the last 4 weeks of the intervention phase (weeks 7-10), measured by Numeric Rating Scale score (NRS, 0-10). Numeric Rating Scale score is on a scale of 0 (no pain) to 10 (worst pain),
Time frame: 10 weeks
Change in Maximum Mouth Opening (MMO)
Change in Maximum Mouth Opening (MMO) will be measured at the end of the baseline at visit 2 and at the end of intervention at visit 3, recorded by the health care provider, and measured in mm.
Time frame: 10 weeks
Change in Jaw pain level
: Change in Jaw pain level by comparing the average daily maximum-pain level in the 4 weeks of the baseline phase (weeks 1-4) to the last 4 weeks of the intervention phase (weeks 7-10), measured by Numeric Rating Scale score (NRS, 0-10). Numeric Rating Scale score is on a scale of 0 (no pain) to 10 (worst pain),
Time frame: 10 weeks
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jun 2027, 12 months after the start.
Of 246 interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 12 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 8, 2026: primary completion Jan 2027 → Jun 2027 and completion Jan 2027 → Jul 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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