Nerivio in adults and adolescents with chronic TMD headache

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label study looks at the safety and potential benefit of Nerivio for managing pain in patients with chronic TMD and related headaches. Eligible participants are 12 years or older with chronic TMD pain lasting at least 6 months and a recent pain level of 4 or higher on a 0-10 scale. Participants must keep their current TMD treatments unchanged during the study and must own a smartphone or tablet for device use. The study is conducted at multiple clinical sites and will observe outcomes related to pain and tolerability over the study period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Is of 12 years of age and older (inclusive; of any gender, race, or ethnicity)
2. Meets diagnostic criteria for chronic TMD (Myalgia and/or Arthralgia) based on the Diagnostic Criteria for TMD (DC/TMD)
3. Has experienced TMD pain for at least 6 months
4. Has experienced TMD pain at level ≥4 on a 0-10 scale for at least 10 days of the last 30 days
5. 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
6. Naïve to REN treatment
7. Willing and able to understand and comply with all study procedures and be available for the duration of the study
8. Has their own smartphone or tablet device that is connected to the internet
9. Provides a signed and dated informed consent form

Exclusion Criteria:

1. 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
2. Has experienced facial trauma or orofacial surgery within 6 weeks prior to the Screening and Baseline Visit
3. Is undergoing current active orthodontic treatment
4. Currently being treated with chemotherapy or radiation therapy
5. Meets the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic or non-chronic migraine
6. Currently taking an opioid medication, whether episodically or daily, within 30 days prior to the Screening and Baseline Visit
7. Has been treated with another investigational drug or treatment within 30 days prior to the Enrollment Visit
8. Taking more than one prescription drug for the treatment of pain (including all types of drugs and modalities, e.g. pill, spray, injection) Note that this criterion does not refer to drug-free based treatments (including split therapy, physical therapy, acupuncture, massage therapy, biofeedback, CBT, or transcutaneous electrical nerve stimulation) for the treatment of pain, which may be used (single or multiple treatments) as long as not changed throughout the study.
9. Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study

Where it's running

• Pain and sleep therapy center
  Newark, Delaware, United States Recruiting
• Proven Endpoints
  Ridgeland, Mississippi, United States Recruiting
• True North neurology
  Commack, New York, United States Recruiting
• Gershon Pain Specialists
  Virginia Beach, Virginia, United States Recruiting

Study contacts

• Study coordinator: Dagan Harris, PhD
• Email: daganh@theranica.com
• Phone: +972542220121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.