Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

Study Overview
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Brief Summary
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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 (Neurolief device, Relievion™).

Official Title
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Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

Conditions
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Migraine

Intervention / Treatment
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* Device: Relievion device- Treatment stimulation
* Device: Relievion Device- Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Relievion device- Treatment stimulation<br>Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation | Device: Relievion device- Treatment stimulation<br>* 1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation<br>* Other names: Neurolief device;|
| Sham Comparator: Sham Comparator: Relievion device- Sham Stimulation<br>Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation | Device: Relievion Device- Sham stimulation<br>* 1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation<br>* Other names: Sham Neurolief device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of pain score (measured on a visual analog scale=VAS) at 1 hour compared to baseline | visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change of pain score (measured by VAS) at 2 hours compared to baseline (if rescue therapy was not used). | visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable painbaseline (if rescue therapy was not used). | 2 hours | 
| Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used). | Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used). | 24 hours | 
| Proportion of patients not having required rescue medication within 24 hours | Proportion of patients not having required rescue medication within 24 hours | 24 hours | 
| Proportion of patients not having required rescue medication at 2 hours compared to baseline. | Proportion of patients not having required rescue medication at 2 hours | 2 hours | 
| Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used). | Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used). | 1, 2, 24 hours | 
| Proportion of responders (responder is defined as decrease of at least 50% in VAS pain score from baseline) at 1,2 and 24 hours from baseline (if rescue therapy was not used). | visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain | 1, 2, 24 hours |