An observational study in Migraine and Acute Treatment of Migraine, sponsored by Theranica. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Theranica · Observational
This is a post-marketing real-world evidence study investigates long-term treatment with the Remote Electrical Neuromodulation (REN) wearable Nerivio device over 3 consecutive years in patients with migraine.
The REN device (Nerivio by Theranica, Israel) is a neuromodulation device approved by the FDA for acute and/or preventive treatment of migraine in patients 8 years old and above. It is a wearable device applied to the upper arm. It stimulates C and Aδ noxious fibers. The REN device is operated by a designated app that is downloaded to the user's phone prior first use of the Nerivio device.
As part of the sign-up process for the Nerivio app, all patients accept the terms of use which specifies that providing personal information is done on their own free will and that their de-identified data may be used for research purposes. Users are not obligated to provide personal information and could treat without providing any feedback. The app includes a secure, personal migraine diary, which enables patients to record and track their migraine and other headaches. At the beginning of each treatment, and again 2 hours after the start of treatment, patients are prompted to record their symptoms, including pain level (none, mild, moderate, severe), functional disability (none, mild limitation, moderate limitation, severe limitation), and an indication of which medications, if any, were taken within that 2-hour time window.
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment by analyzing data of patients who used the Nerivio device for consecutive 3 years: the following outcome will be assessed:
Primary endpoint:
1. Lack of Tachyphylaxis - No clinically meaningful change in treatment intensity between years.
Secondary endpoints:
Together, these four objectives provide a comprehensive evaluation of the long-term tolerability, safety, and efficacy of the Nerivio device using a real-world dataset.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 244 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine 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.
People with migraine (age > 12) using the Nerivio device for the treatment of their migraine.
Exclusion Criteria:
None
Patients with migraine who were prescribed the REN wearable device for the treatment of their migraine and began treating between December 2019 and September 2021
Device: Nerivio
Remote electrical neuromodulation (REN) wearable device for the treatment of migraine. The device delivers 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.
Long Term Lack of Tachyphylaxis
No clinically meaningful change in treatment intensity between the years (defined as change of less than 2.5 of treatment intensity units between consecutive years).
Time frame: 3 Years
Long Term Consistent Pain Relief at 2 Hours Post-treatment
Constant proportion of subjects reporting relief from headache pain at 2 hours post-treatment in at least 50% of their treatments between the years. Pain relief is defined as an improvement from severe or moderate pain at treatment initiation to mild or no pain. Pain level is reported using a 4-point Likert scale (0 - No pain, 1 - Mild pain, 2 - Moderate pain,3- Severe pain)
Time frame: 3 Years
Long Term Consistent Pain Freedom at 2 Hours Post-treatment
Constant proportion of subjects reporting freedom from headache pain at 2 hours post-treatment in at least 50% of their treatments between the years. Pain freedom is defined as the disappearance of pain from severe, moderate, or mild headaches at treatment initiation to no pain 2 hours later.
Time frame: 3 Years
Long Term Consistent Functional Disability Relief at 2 Hours Post-treatment
Constant proportion of subjects reporting functional disability at the beginning of the treatment and reported improvement of at least one level of functional disability at 2 hours post-treatment in at least 50% of their treatments between the years. Functional disability level is reported using a 4-point Likert scale (0-No limitation, 1-Some limitation, 2-Moderate limitation, 3-Severe limitation)
Time frame: 3 Years
Long Term Consistent Functional Disability disappearance at 2 Hours Post-treatment
Constant proportion of subjects reporting functional disability at the beginning of the treatment and reported no functional disability at 2 hours post-treatment in at least 50% of their treatments between the years. Functional disability level is reported using a 4-point Likert scale (0-No limitation, 1-Some limitation, 2-Moderate limitation, 3-Severe limitation).
Time frame: 3 Years
Long Term Consistent Freedom from Associated Symptoms at 2-Hours Post-treatment
Constant proportion of subjects reporting presence of associated symptoms (photophobia, phonophobia, nausea and/or vomiting) at the beginning of the treatment and reporting freedom from associated symptoms at 2 hours post-treatment in at least 50% of their treatments between the years. Associated symptoms are reported as present or absent
Time frame: 3 years
Long Term Utilization of Nerivio
Constant average number of monthly Nerivio treatments per year between the years.
Time frame: 3 Years
Device Related Adverse Events
Incidence of device-related adverse events reported by subjects
Time frame: 3 Years
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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