Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06023953
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2023-08-29
Brief Title:
Migraine With and Without Aura Response to Remote Electrical Neuromodulation REN Treatment
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
Comparison of Migraine With and Without Aura in a Large Cohort Disease Characteristics and Response to Remote Electrical Neuromodulation REN Treatment
Status:
COMPLETED
Status Verified Date:
2023-08
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 acute treatment of migraine with a Remote Electrical Neuromodulation REN device Nerivio in migraine patients with and without aura as well as characterizing demographic and attack characteristic differences between migraine patients with and without aura
Safety will be assessed by the number and type of device-related adverse events Efficacy will be evaluated as a change in headache pain severity from baseline to 2 hours post-treatment Disease characteristics will look into demographic and attack differences between patients with and without aura
Safety will be assessed by the number and type of device-related adverse events Efficacy will be evaluated as a change in headache pain severity from baseline to 2 hours post-treatment Disease characteristics will look into demographic and attack differences between patients with and without aura
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 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 smartphone application that is downloaded to the users 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 specify 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 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 the presence or absence of aura pain level none mild moderate severe functional disability none mild limitation moderate limitation severe limitation presence of associated symptoms photophobia phonophobia and nausea and an indication of which medications if any were taken within that 2-hour time window
Post-marketing surveillance is designed to assess the safety and efficacy of REN in larger and more diverse populations than in clinical trials and in various real-world environments and situations As a digital therapeutic device ie electroceutical the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment in patients with and without aura by analyzing data from patients who used the Nerivio device The following outcomes will be assessed
1 - Safety - all adverse events that were reported during the studys period
2 - Efficacy - pain relief freedom from pain improvement in functional disability and return to normal function no disability at 2 hours post-treatment 3 - Disease severity -severe headache pain presence of associated symptoms
Together these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine with or without aura
As part of the sign-up process for the Nerivio app all patients accept the terms of use which specify 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 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 the presence or absence of aura pain level none mild moderate severe functional disability none mild limitation moderate limitation severe limitation presence of associated symptoms photophobia phonophobia and nausea and an indication of which medications if any were taken within that 2-hour time window
Post-marketing surveillance is designed to assess the safety and efficacy of REN in larger and more diverse populations than in clinical trials and in various real-world environments and situations As a digital therapeutic device ie electroceutical the REN device enables prospective collection of electronic patient-reported outcomes in real-world clinical practice
This post-marketing RWE study investigates the safety and efficacy of the Nerivio treatment in patients with and without aura by analyzing data from patients who used the Nerivio device The following outcomes will be assessed
1 - Safety - all adverse events that were reported during the studys period
2 - Efficacy - pain relief freedom from pain improvement in functional disability and return to normal function no disability at 2 hours post-treatment 3 - Disease severity -severe headache pain presence of associated symptoms
Together these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine with or without aura
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