A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.
NCT ID: NCT03185559
Last Updated: 2018-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
8 participants
INTERVENTIONAL
2017-07-23
2018-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Relievion device- Treatment stimulation
Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation
Relievion Device- Treatment Stimulation
1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation
Relievion device- Sham Stimulation
Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation
Relievion Device- Sham stimulation
1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation
Interventions
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Relievion Device- Treatment Stimulation
1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation
Relievion Device- Sham stimulation
1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Capable of cooperating with the study protocol and to sign an informed consent.
Exclusion Criteria
* 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 (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 3 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 of reproductive age not using efficient contraceptive method.
* History of cerebrovascular event.
* Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
18 Years
65 Years
ALL
No
Sponsors
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Neurolief Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Colin Klein, Dr
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center, Kfar Saba, Israel
Locations
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Meir General Hospital
Kfar Saba, , Israel
Countries
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Other Identifiers
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NRLF-0038-17-MMC-CTIL
Identifier Type: -
Identifier Source: org_study_id
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