Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)

Migraine Clinical Trial

Official title:

Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06138756
• Other study ID #: RWE009
• Status: Completed
• Start date: October 1, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: November 2023
• Source: Theranica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 and/or 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 REN's real-world safety and efficacy in pre-adolescents, 9-11 years old.

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 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 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 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 (i.e., 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 study's 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

• Subject age is between 9 to 11 (included) at the date of the REN treatment

• Subject used the Nerivio device at least once

Exclusion Criteria:

• Treatments shorter than 30 minutes

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• Nerivio
Neriio is a remote electrical neuromodulation (REN) device for the treatment of migraine

Locations

Country	Name	City	State
Israel	Theranica Bio-Electronics Ltd	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Theranica

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Related Adverse Events	Incidence of device-related adverse events reported by subjects	2 hours
Secondary	Consistent Headache Relief at 2 Hours Post-treatment	The proportion of subjects reporting headache relief at 2 hours post-treatment in at least 50% of all their treatments.; Headache relief is defined as an improvement from severe or moderate pain to mild or no pain.	2 hours
Secondary	Consistent Freedom From Headache at 2 Hours Post-treatment	The proportion of subjects reporting freedom from headache at 2 hours post-treatment in at least 50% of all their treatments.; Pain freedom is defined as the disappearance of headache from severe, moderate, or mild headache at treatment initiation to no headache 2 hours later	2 hours
Secondary	Associated Symptoms Freedom	The proportion of subjects reporting the presence of each of the migraine-associated symptoms (photophobia, phonophobia, nausea) at the beginning of treatment and reported their absence in at least 50% of their attacks.	2 hours
Secondary	Consistent Functional Disability Relief at 2 Hours Post-treatment	The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported improvement of at least one level of Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.	2 hours
Secondary	Consistent Functional Disability disappearance at 2 Hours Post-treatment	The proportion of subjects who reported having Functional Disability at the beginning of the treatment and reported no Functional Disability at 2 hours post-treatment in at least 50% of all their treatments.	2 hours