A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating 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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A Prospective, Randomized, Double-blind, Parallel-group, Sham Controlled Single-center Pivotal Clinical Investigation to Evaluate the Clinical Safety and Performance of Self-administered Home-use Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation Device (Relievion™) in Treating 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: History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III (International Classification of Headache Disorders) beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction). Capable of cooperating 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 (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).

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: 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 |
| --- | --- | --- |
| Pain Visual Analogue Scale (VAS) Change from basline to 1 hour | Mean change of pain score (measured on a visual analog scale) at 1 hour compared to baseline (if rescue therapy was not used) | 1 Hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS change from baseline to 30 minutes | Mean change of pain score (measured on a visual analog scale) at 30 minutes compared to baseline (if rescue therapy was not used). | 30 minutes | 
| Pain VAS change from baseline to 2 hours | Mean change of pain score (measured on a visual analog scale) at 2 hours compared to baseline (if rescue therapy was not used). | 2 Hours | 
| Pain VAS change from baseline to 24 hours | Mean change of pain score (measured on a visual analog scale) at 24 hours compared to baseline (if rescue therapy was not used). | 24 Hours | 
| Pain VAS change from baseline to 48 hours | Mean change of pain score (measured on a visual analog scale) at 48 hours compared to baseline (if rescue therapy was not used). | 48 Hours | 
| Rescue medication at 2 hours | Proportion of patients not having required rescue medication at 2 hours | 2 hours | 
| Rescue medication within 24 hours | Proportion of patients not having required rescue medication within 24 hours | 24 hours | 
| Rescue medication within 48 hours | Proportion of patients not having required rescue medication within 48 hours | 48 hours |