Nerivio REN Device for Migraine

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Theranica

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Ongoing

What You Need to Know Before You Apply

What is the purpose of this trial?

Among US veterans, migraine is a prevalent and disabling neurological disorder, creating a clinical need for effective treatment options.

This real-world evidence (RWE) study assessed the use, effectiveness, and safety of the REN wearable among veterans with migraine, with a primary focus on whether they need rescue medications following REN treatment. Findings from this study may help guide clinical decision-making as veterans and providers craft treatment plans that include non-pharmacologic options

Who Is on the Research Team?

Alit Stark-Inbar, PhD

Principal Investigator

Theranica

Are You a Good Fit for This Trial?

This trial is for US veterans who have migraines and are using the Nerivio REN device. Participants must be VA patients prescribed with this device, have used it at least twice, and completed necessary questionnaires.

Inclusion Criteria

I am a VA patient prescribed the Nerivio REN device.

I have completed at least two REN treatments and filled out the required questionnaires.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the REN wearable device for migraine treatment and report baseline pain, followed by a 2-hour post-treatment questionnaire

Ongoing

At least 2 sessions

Follow-up

Participants are monitored for safety and effectiveness, including device safety and adverse events

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Nerivio REN device

Trial Overview

The study examines how veterans use the Nerivio REN wearable device to treat migraines. It focuses on its effectiveness, particularly if users need less additional medication after treatment.

How Is the Trial Designed?

Group I: Nerivio treatment Active Control 1 Intervention

VA patients who were prescribed with the Nerivio REN device and treated with the device and reported baseline pain were also presented with a 2-hours post-treatment questionnaire at least twice..

Who Is Running the Clinical Trial?

Theranica

Lead Sponsor

Trials

21

Recruited

41,700+