Clinical trial NCT06138756: Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)
Official title: Acute Treatment of Migraine in Pre-Adolescents: Real-World Analysis of Remote Electrical Neuromodulation (REN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: REN
Nerivio
Adolescence
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 293
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pre-adolescence (age 9-11) who suffers from migraine and are using the Nerivio device for acute treatment of migraine.

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Device Related Adverse Events
timeFrame: 2 hours
Secondary outcomes:
measure: Consistent Headache Relief at 2 Hours Post-treatment
timeFrame: 2 hours
measure: Consistent Freedom From Headache at 2 Hours Post-treatment
timeFrame: 2 hours
measure: Associated Symptoms Freedom
timeFrame: 2 hours
measure: Consistent Functional Disability Relief at 2 Hours Post-treatment
timeFrame: 2 hours
measure: Consistent Functional Disability disappearance at 2 Hours Post-treatment
timeFrame: 2 hours
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Theranica USA Inc
state: New Jersey
city: Netanya
country: Israel
facility: Theranica Bio-Electronics Ltd
Study officials:
affiliation: Theranica
name: Alit Stark Inbar,, PhD
role: PRINCIPAL_INVESTIGATOR
References: