Status:
COMPLETED
Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)
Lead Sponsor:
Theranica
Conditions:
Migraine
Eligibility:
All Genders
6-12 years
Brief Summary
Migraine is a prevalent neurological disorder that severely impacts both children and adolescents, causing significant disability. Remote Electrical Neuromodulation (REN) is a nonpharmacological, pres...
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
- Subject age is between 6 to 12 at the date of the REN treatment
- Subject used the Nerivio device at least once
Exclusion
- None
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT06138756
Start Date
October 1 2023
End Date
June 1 2024
Last Update
September 15 2025
Active Locations (2)
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1
Theranica USA Inc
Bridgewater, New Jersey, United States, 08807
2
Theranica Bio-Electronics Ltd
Netanya, Israel, 4250438