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
1 other identifier
observational
244
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2024
CompletedFirst Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
December 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2024
CompletedJuly 17, 2025
April 1, 2025
19 days
December 12, 2024
July 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
3 Years
Secondary Outcomes (7)
Long Term Consistent Pain Relief at 2 Hours Post-treatment
3 Years
Long Term Consistent Pain Freedom at 2 Hours Post-treatment
3 Years
Long Term Consistent Functional Disability Relief at 2 Hours Post-treatment
3 Years
Long Term Consistent Functional Disability disappearance at 2 Hours Post-treatment
3 Years
Long Term Consistent Freedom from Associated Symptoms at 2-Hours Post-treatment
3 years
- +2 more secondary outcomes
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
People with migraine (age \> 12) using the Nerivio device for the treatment of their migraine.
You may qualify if:
- \- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Theranicalead
Study Sites (1)
Theranica Bio-Elewctronics Inc
Bridgewater, New Jersey, 08807, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2024
First Posted
December 17, 2024
Study Start
December 1, 2024
Primary Completion
December 20, 2024
Study Completion
December 22, 2024
Last Updated
July 17, 2025
Record last verified: 2025-04