Nerivio Long-term Usage in Patients With Migraine
Real-World Evidence (RWE) Data Analysis of 3-year Usage of Nerivio, a Remote Electrical Neurostimulation (REN) Device In Patients With Migraine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Consistent effectiveness - Stable pain relief, freedom from pain, functional disability relief, return to normal function (no disability), and freedom from associated symptoms at 2 hours post-treatment relative to baseline in at least 50% of the treatments between years.
- Utilization - Stable average number of monthly Nerivio treatments per year between years.
- Safety and tolerability- Number and severity of device related adverse events.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Jersey
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Bridgewater, New Jersey, United States, 08807
- Theranica Bio-Elewctronics Inc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- - Users who began treating with the REN wearable device between December 2019 and September 2021.
- - Users who treated migraine attacks consecutively for 3 years, with at least 9 months per year
- - Users with at least one treatment recorded in each of the counted months.
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Nerivio users
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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Long Term Lack of Tachyphylaxis
Time Frame: 3 Years
|
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).
|
3 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Device Related Adverse Events
Time Frame: 3 Years
|
Incidence of device-related adverse events reported by subjects
|
3 Years
|
|
Long Term Consistent Pain Relief at 2 Hours Post-treatment
Time Frame: 3 Years
|
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) |
3 Years
|
|
Long Term Consistent Pain Freedom at 2 Hours Post-treatment
Time Frame: 3 Years
|
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. |
3 Years
|
|
Long Term Consistent Functional Disability Relief at 2 Hours Post-treatment
Time Frame: 3 Years
|
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) |
3 Years
|
|
Long Term Consistent Functional Disability disappearance at 2 Hours Post-treatment
Time Frame: 3 Years
|
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). |
3 Years
|
|
Long Term Consistent Freedom from Associated Symptoms at 2-Hours Post-treatment
Time Frame: 3 years
|
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 |
3 years
|
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Long Term Utilization of Nerivio
Time Frame: 3 Years
|
Constant average number of monthly Nerivio treatments per year between the years.
|
3 Years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RWE-008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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