A randomized double-blind sham-controlled clinical study of the safety and efficacy of Nerivio Migra for the acute treatment of migraine in adolescents

Brief description of study

This research is being done to evaluate a new investigational non-invasive drug-free acute treatment of migraine in adolescents aged 12-17 years old. The Nerivio device is indicated by the FDA for acute treatment of migraine with or without aura in patients 18 years of age or older who do not have chronic migraine. The Nerivio device is investigational, which means it is not approved by the FDA for treatment of children under 18 years. The purpose of this study is to assess the effect of the Nerivio device in the adolescence population. The Nerivio is a non-invasive neuromodulation device operated via a smartphone application. The device is worn on the upper arm, and the treatment is self-administered at the onset of a migraine attack. The device delivers non-painful electrical pulses to the skin that stimulate the body to initiate a pain inhibition mechanism in the brain. During the treatment, the users can adjust the intensity of the pulses according to how they tolerate it

Clinical Study Identifier: s19-00766
ClinicalTrials.gov Identifier: NCT04089761
Principal Investigator: Thomas Berk
Currently Recruiting

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