Migraine Treatment With Nerivio Migra Neurostimulation Device

Stopped early · Not applicable · Has a placebo group

Conditions studied: Acute Migraine

In brief

This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.

Key facts

Study ID

NCT03076515

Run by

Theranica

People needed

120

Starts

2017-04-02

Expected to finish

2018-04-01

Last updated by the study team

2025-07-17

Who can join

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

You may qualify if…

• Patient is 18-75 years old.
• Patient meeting the ICHD-3 diagnostic criteria for migraine with and without aura.
• Patients reporting 2-8 migraine attacks per month.
• Patient must be able and willing to comply with the protocol.
• Patient must be able and willing to provide written informed consent.
• Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test) and must be willing to use adequate contraceptive means during the study

You may not qualify if…

• Has other significant pain problem that in the opinion of the investigator may confound the study assessments
• Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
• Known uncontrolled epilepsy.
• Use of Cannabis including medical use.
• Has chronic migraine (more than 15 headache days per month).
• Changed usage or dosage of migraine preventive medications in the last two months
• Has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
• Is participating in any other clinical study. -

Where it is running

• MedStar - Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Albany Medical College — Albany, New York, United States
• Hartford Healthcare Headache Center — Hartford, New York, United States
• Northwell Health, Inc — New York, New York, United States
• Hillel Yaffe Medical Center — Hadera, Israel
• Herzeliya medical Center — Herzliya, Israel
• Maccabi Healthcare neurology clinics — Kfar Saba, Israel
• Western Galilee Medical Center — Nahariya, Israel

Full record on ClinicalTrials.gov

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