Nerivio REN Device for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on testing a device called the Nerivio REN, which aims to treat migraines without medication. Researchers aim to determine if veterans with migraines require fewer rescue medications after using this wearable device. The goal is to assess whether the device can reliably help veterans manage their migraines. Veterans who have been prescribed this device, used it at least twice, and completed related questionnaires are suitable candidates for this study. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on using the REN device for migraines, so you may want to discuss this with the trial coordinators or your doctor.
What is the safety track record for the Nerivio REN device?
Research has shown that the Nerivio REN device is safe for treating migraines. Studies have demonstrated that regular use over a year is both safe and effective. It works well for adults, teens, and children with migraines. The device is non-invasive, requiring neither surgery nor medication, and the FDA has approved it for treating migraines in individuals over 12 years old. Users find it easy to use, with no serious side effects reported. This makes Nerivio a reliable option for those seeking drug-free migraine relief.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about the Nerivio REN device for migraine treatment because it offers a drug-free approach, using remote electrical neuromodulation (REN). Unlike standard migraine treatments that often involve oral or injectable medications like triptans or NSAIDs, the Nerivio device is worn on the upper arm and uses electrical pulses to alleviate migraine symptoms. This method not only avoids medication-related side effects but also provides a convenient, on-the-go solution that can be used at the first sign of a migraine.
What evidence suggests that the Nerivio REN device is effective for migraine?
Research shows that the Nerivio REN device, used by participants in this trial, effectively treats migraines. Studies have found that it provides steady and long-lasting relief without requiring increased usage over time. In one study, individuals using the REN device experienced fewer migraine days each month compared to those using a placebo device. The device is safe and has helped both adults and children manage migraines effectively. This makes it a promising non-drug option for those seeking migraine relief.34678
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the REN wearable device for migraine treatment and report baseline pain, followed by a 2-hour post-treatment questionnaire
Follow-up
Participants are monitored for safety and effectiveness, including device safety and adverse events
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?
1
Treatment groups
Active Control
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..
Find a Clinic Near You
Who Is Running the Clinical Trial?
Theranica
Lead Sponsor
Citations
Theranica's Nerivio® REN Wearable Featured in ...
"The results show that REN therapy provides consistent, long-term effectiveness without the need for a dosage (intensity) increase over time ...
One-Year Consistent Safety, Utilization, and Efficacy ...
REN is a safe and well-tolerated acute migraine treatment, with stable efficacy and utilization over 1 year, making it an advantageous non-drug option.
Nerivio® Clinical Trials: Proven Science Behind Migraine ...
The safety and efficacy of Nerivio have been consistently demonstrated across a broad patient population, including adults, adolescents, and children with ...
4.
neurologylive.com
neurologylive.com/view/monitoring-long-term-efficacy-migraine-wearable-device-over-3-years-alit-stark-inbarMonitoring Long-Term Efficacy of Migraine Wearable ...
A long-term study demonstrated that the REN wearable maintained consistent efficacy for migraine treatment over 3 years, with no signs of ...
What Three Randomized Placebo Controlled Trials Reveal ...
In this large multicenter trial, [3] REN users experienced a mean reduction of 4.0 migraine days/month, compared to 1.3 in the sham group (p < .001). The ...
Nerivio® REN Wearable: Indication & Safety Information
Discover the indications and safety information for Nerivio® REN Wearable, an FDA-cleared, non-invasive device for migraine treatment and prevention.
7.
nerivio.com
nerivio.com/clinical-trials/real-world-evidence-rwe-data-analysis-of-1-year-consecutive-use-of-nerivio-nct05760638One-Year Consistent Safety, Utilization, and Efficacy ...
This study demonstrated that long-term use of Nerivio (at least once per month for 12 months) was safe and effective. The device showed consistent efficacy, ...
Assessment of Safety and Efficacy of Nerivio for ...
Nerivio is a neuromodulation device approved for the acute treatment of migraine with or without aura in patients 12 years of age or older. The device utilizes ...
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