Status:
COMPLETED
Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Lead Sponsor:
Neurolief Ltd.
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (...
Eligibility Criteria
Inclusion
- Males and females Ages of 18 to 65 years old.
- History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD (International Classification of Headache Disorders)-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
- Capable to corporate with the study protocol and to sign an informed consent.
Exclusion
- Patients having received Botox treatment in the head region in the prior 4 months.
- Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
- History of Medication Overuse Headache.
- Patients using opioid medication.
- Allodynia: intolerance to supraorbital and/or occipital neurostimulation that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 10 minutes of neurostimulation).
- Implanted metal or electrical devices in the head (not including dental implants).
- Patient having had a previous experience with the Relievion™ device.
- Patients who have concomitant epilepsy.
- History of neurosurgical interventions.
- Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- History of drug abuse or alcoholism.
- Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
- Skin lesion or inflammation at the region of the stimulating electrodes.
- Personality or somatoform disorder.
- Pregnancy or Lactation.
- Women with child bearing potential without medically acceptable method of contraception.
- History of cerebrovascular event.
- Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
- Patients using Cannabis
- Patients with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters.
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03398668
Start Date
February 22 2018
End Date
December 30 2018
Last Update
March 13 2019
Active Locations (1)
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1
Laniado Medcial Center
Netanya, Israel