Migraine
Conditions
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 (Neurolief device, Relievion™).
Interventions
1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation
1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation
Sponsors
Neurolief Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Visual Analogue Scale (VAS) Change from basline to 1 hour | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain VAS change from baseline to 2 hours | 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). |
| Pain VAS change from baseline to 24 hours | 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). |
| Pain VAS change from baseline to 48 hours | 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). |
| Pain VAS change from baseline to 30 minutes | 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). |
| Rescue medication within 24 hours | 24 hours | Proportion of patients not having required rescue medication within 24 hours |
| Rescue medication within 48 hours | 48 hours | Proportion of patients not having required rescue medication within 48 hours |
| Rescue medication at 2 hours | 2 hours | Proportion of patients not having required rescue medication at 2 hours |
Countries
Israel
Outcome results
None listed