Status:
COMPLETED
Migraine With and Without Aura Characteristics and Response to Remote Electrical Neuromodulation (REN) Treatment
Lead Sponsor:
Theranica
Conditions:
Migraine With Aura
Migraine Without Aura
Eligibility:
All Genders
8+ years
Brief Summary
This is a Post-marketing, real-world evidence study investigating the safety and efficacy of the acute treatment of migraine with a Remote Electrical Neuromodulation (REN) device (Nerivio) in migraine...
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 12 years old and above. It is a wearable dev...
Eligibility Criteria
Inclusion
- Users aged 8 years old and above
- Users who treated their migraine attacks with the Nerivio device at least twice
- Users who prospectively reported the presence of aura in at least two treatment reports (reporting at least twice having aura) , OR:
- Users who prospectively reported the absence of aura in all of their reports, with at least two reports
Exclusion
- Users who prospectively reported having aura only once
Key Trial Info
Start Date :
July 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
31715 Patients enrolled
Trial Details
Trial ID
NCT06023953
Start Date
July 1 2023
End Date
December 1 2024
Last Update
August 15 2025
Active Locations (1)
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1
Theranica Bio-Electronics Ltd
Netanya, Israel, 4520438