Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06138756
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-11-11
Brief Title:
Acute Treatment of Migraine in Pre-Adolescents Real-World Analysis of Remote Electrical Neuromodulation REN
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
Acute Treatment of Migraine in Pre-Adolescents Real-World Analysis of Remote Electrical Neuromodulation REN
Status:
COMPLETED
Status Verified Date:
2023-11
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:
Migraine is a prevalent neurological disorder that severely impacts both children and adolescents causing significant disability Remote Electrical Neuromodulation REN is a nonpharmacological prescribed wearable device FDA-cleared for acute andor preventive treatment of migraine with or without aura in patients 12 years or older Multiple studies have shown that REN has high safety tolerability and efficacy in adults and adolescents This study aims to evaluate RENs real-world safety and efficacy in pre-adolescents 9-11 years old
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 secure 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 pre-adolescence migraine 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 improvement in migraine-associated symptoms following the treatment
Together these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine in this target population
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 secure 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 pre-adolescence migraine 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 improvement in migraine-associated symptoms following the treatment
Together these objectives provide a comprehensive evaluation of the effect of REN as a treatment for migraine in this target 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