Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine

Completed · Not applicable

Conditions studied: Chronic Migraine

In brief

This study is intended to evaluate the efficacy and safety of Nerivio, an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine, for the acute treatment of migraine in people with chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The study duration consists of a 4 weeks of active treatment with the device in about 40 patients.

Key facts

Study ID

NCT04161807

Run by

Theranica

People needed

42

Starts

2019-09-18

Expected to finish

2020-02-18

Last updated by the study team

2021-02-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants aged 18-75 years old.
• Participants meeting the ICHD-3 diagnostic criteria for chronic migraine
• Participants have personal access to a smartphone
• Participants must be able and willing to comply with the protocol
• Participants must be able and willing to provide written informed consent

You may not qualify if…

• Participants with an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
• Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
• Participants with uncontrolled epilepsy.
• Lack of efficacy, after an adequate therapeutic trial, of at least two migraine specific acute medications
• Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study
• Pregnant, trying to get pregnant or breastfeeding female participants
• Subjects participating in any other interventional clinical study.
• Participants without basic cognitive and motor skills needed to operate a smartphone
• Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
• Participants who have previous experience with the device

Where it is running

• Health Quest Medical Practice, PC — Lagrangeville, New York, United States
• Meir Medical Center — Kfar Saba, Israel

Full record on ClinicalTrials.gov

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