Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-02 @ 8:45 PM
Study NCT ID:
NCT06738056
Status:
COMPLETED
Last Update Posted:
2025-07-17
First Post:
2024-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nerivio Long-term Usage in Patients With Migraine
Sponsor:
Theranica
Organization:
Study Overview
Official Title:
Real-World Evidence (RWE) Data Analysis of 3-year Usage of Nerivio, a Remote Electrical Neurostimulation (REN) Device In Patients With Migraine
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
1. 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.
2. Utilization - Stable average number of monthly Nerivio treatments per year between years.
3. 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.
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:
1. 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.
2. Utilization - Stable average number of monthly Nerivio treatments per year between years.
3. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: