Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05769322
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2023-03-02
Brief Title:
Real World Data Analysis Impact of High-Frequency REN Treatments as Migraine Preventive Therapy in Adolescence
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
Remote Electrical Neuromodulation REN Wearable Device for Adolescents With Migraine Real World Study of High-Frequency Users Suggest Preventive Effects
Status:
COMPLETED
Status Verified Date:
2023-02
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 study investigating the safety and efficacy of the REN device Nerivio by Theranica ISRAEL in adolescents with migraine The data analysis will test the ability of Frequent use of REN for the acute treatment of migraine to reduce the number of monthly migraine days in subsequent months suggesting potential preventive benefits
Detailed Description:
The REN device Nerivio by Theranica ISRAEL is a neuromodulation device approved by the FDA for acute andor preventive treatment of migraine in patients of 12 years old and above It is a wearable device applied to the upper arm It stimulates C and Aδ noxious fibers using a modulated symmetrical biphasic square pulse with a pulse width of 400 μs modulated frequency of 100-120 Hz and up to 40 mA output current which the patient can adjust The REN device is operated by a designated app that is downloaded to the users phone prior first use of the Nerivio device
As part of the sign-up process to the Nerivio app all patients accept the terms of use which specify that providing personal information is done by 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 secured personal migraine diary which enables patients to record and track their migraines 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 No limitation Some 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 potential of high usage of Nerivio for the acute treatment of migraine on migraine prevention using the following outcomes
1 - reduction in mean monthly migraine treatment days MMTD
2 - acute treatment efficacy measured 2 h post-treatment
3 - improve in functional disability
4 - Device safety
Together these objectives may provide a comprehensive evaluation of the impact of the high usage of Nerivio for acute treatment as a migraine preventive tool in the migraine adolescent population
As part of the sign-up process to the Nerivio app all patients accept the terms of use which specify that providing personal information is done by 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 secured personal migraine diary which enables patients to record and track their migraines 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 No limitation Some 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 potential of high usage of Nerivio for the acute treatment of migraine on migraine prevention using the following outcomes
1 - reduction in mean monthly migraine treatment days MMTD
2 - acute treatment efficacy measured 2 h post-treatment
3 - improve in functional disability
4 - Device safety
Together these objectives may provide a comprehensive evaluation of the impact of the high usage of Nerivio for acute treatment as a migraine preventive tool in the migraine adolescent population
Study Oversight
Has Oversight DMC:
None
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?:
None