Evaluation of a Novel Device for Treatment of Migraine Headache

Completed · Not applicable · Has a placebo group

Conditions studied: Migraine Without Aura, Migraine With Aura

In brief

Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment. Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches including migraine. It is tolerable by patients and associated with no adverse effects. The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere. 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. The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra electro stimulation device for the reduction of migraine headache during an attack of migraine with or without aura. The study is intended for subject with 2-8 migraine episodes per month. patients will receive the device, either an active or a placebo type, and will be asked to use the device at home or in any location that they will be when the migraine starts. The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral nervous system at onset of a migraine attack significantly reduce headache pain demonstrated by a significant difference between proportions of responders to the active treatment stimulation in comparison to proportion of responders that will use a placebo device.

Key facts

Study ID

NCT03361423

Run by

Theranica

People needed

296

Starts

2017-12-17

Expected to finish

2018-12-25

Last updated by the study team

2021-05-19

Who can join

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

You may qualify if…

• Subjects age 18-75 years old.
• Subjects meet the ICHD-3 diagnostic criteria for migraine with or without aura
• Subjects report 2-8 migraine attacks per month.
• Stable migraine preventive medications in the last two months prior to recruitment (No change in usage or dosage).
• Subjects must be able and willing to comply with the protocol
• Subjects must be able and willing to provide written informed consent

You may not qualify if…

• Subject has other significant pain, medical or psychologic problems that in the opinion of the investigator may confound the study assessments
• Subject has an implanted 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).
• Subject has known uncontrolled epilepsy.
• Any use of Cannabis including medical use.
• Subject has >10 headache days per month.
• Subject has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
• Subject is participating in any other clinical study.
• The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
• Pregnant, or trying to get pregnant
• Subject is experiencing a menstrually related migraine
• Received OnabotulinumtoxinA or any botulinum toxin injections for migraine within the previous month
• Received parenteral infusions for migraine within the previous 2 weeks.
• Subject participated in a previous study with the Nerivio Migra 1 device

Where it is running

• Hartford Headache Center — Hartford, Connecticut, United States
• Clinvest Research — Springfield, Missouri, United States
• Mercy Hospital — St Louis, Missouri, United States
• Clinical Reseach Consortium — Las Vegas, Nevada, United States
• Northwell Health, Inc — New York, New York, United States
• Rochester Clinical Research — Rochester, New York, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Rambam Medical Center — Haifa, Israel
• wolfson Medical Center — Holon, Israel
• Meir Medical Center — Kfar Saba, Israel
• Belinson Medical Center — Petah Tikva, Israel
• Souraskyr Medical center - Ichilov — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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