Clinical trial NCT06023953: Migraine with and Without Aura Response to Remote Electrical Neuromodulation (REN) Treatment
Official title: Comparison of Migraine with and Without Aura in a Large Cohort: Disease Characteristics and Response to Remote Electrical Neuromodulation (REN) Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine with Aura
Migraine Without Aura
Keywords: migraine
Nerivio
REN
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2023-09-05
Enrollment: 24446
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with migraine by their HCP and were prescribed Nerivio for treatment of acute migraine

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.

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 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 (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 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 study's 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.

Eligibility criteria: Inclusion Criteria:

* Age 12 years old and above
* REN users across the USA who created Nerivio accounts between October 2019 and February 2023.
* Treated acute migraine at least once with Nerivio device
* Reported at least one treatment questionnaire at T=0h and T=2h

Exclusion Criteria:

* Treatments shorter than 30 minutes

Primary outcomes:
measure: Consistent Headache Relief at 2 Hours Post-treatment
timeFrame: 2 hours
measure: Device Related Adverse Events
timeFrame: 40 Months
Secondary outcomes:
measure: Consistent Freedom From Headache at 2 Hours Post-treatment
timeFrame: 2 hours
measure: Severe Headache Pain during migraine attack
timeFrame: 2 hours
measure: Associated Symptoms Relief
timeFrame: 2 hours
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Theranica Bio-Electronics Ltd
Study officials:
affiliation: Theranica Bio-Electronics Ltd
name: Alit Stark Inbar, PhD
role: PRINCIPAL_INVESTIGATOR
References: