Clinical trial NCT06976723: Nerivio Efficacy by Time of Treatment Onset
Official title: The Effect of Treatment Onset Time on Acute Treatment Efficacy in Migraine Patients Using Remote Electrical Neuromodulation (REN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Migraine
Acute Treatment of Migraine
Keywords: Nerivio
Remote Electrical Neuromodulation
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 70000
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Post-marketing study investigating the impact of treatment time onset with Nerivio on the efficacy of Remote Electrical Neuromodulation (REN) for the acute treatment of migraine.

Efficacy will be evaluated as a change in headache pain severity and functional disability from baseline to 2 hours post-treatment in at least 50% of the treatments, based on the treatment start time from the beginning of the migraine attack.

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 8 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 app that is downloaded to the user's phone prior to 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 at 2 hours after the start of treatment, patients are prompted to record their symptoms, including pain level (none, mild, moderate, severe), functional disability (None, Mild limitation, Moderate limitation, Severe limitation), 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, utilization, and efficacy in larger and more diverse populations 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 impact of early treatment (within 60 minutes from the migraine onset) vs. late treatment (over 60 minutes from the migraine onset) on the effectiveness of the Nerivio treatment of acute migraine.

for this study, treatments were classified as 'early treatments' if Nerivcio was administered within 1-hour (60 minutes) of migraine onset and classified as 'late treatments' if administered more than 1-hour (60 minutes) after onset. On a patient level, a patient was defined as an 'early-treater' if s/he had reported treatment onset in at least two treatments and had treated early in 50% or more of treatments. A patient was defined as a 'late-treater' if s/he had reported treatment onset in at least two treatments and had treated late in more than 50% of treatments.

The following efficacy outcome will be assessed - Pain Relief, Pain Freedom, Functional Disability Relief, Functional Disability Freedom, Freedom from each migraine-associated symptom (Photophobia, Phonophobia, Nausea/Vomiting) and Consistent Efficacy.

Eligibility criteria: Inclusion Criteria:

* • Users who had reported treatment onset time in at least one treatment through the REN companion smartphone app

Exclusion Criteria:

* • Treatments that included medications for acute treatment of migraine

Primary outcomes:
measure: Pain Relief
timeFrame: 2 hours post treatment
measure: Pain Freedom:
timeFrame: 2 hours post treatment
Secondary outcomes:
measure: Functional Disability Relief
timeFrame: 2 hours post treatment
measure: Functional Disability Freedom
timeFrame: 2 hours post treatment
measure: Freedom from each migraine-associated symptom (Photophobia, Phonophobia, Nausea/Vomiting)
timeFrame: 2 hours post treatment
measure: Consistent efficacy
timeFrame: 2 hours post treatment
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Theranica Bio-Electronics Inc
state: New Jersey
Study officials:
References: