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
1. Males and females Ages of 18 to 65 years old. 2. 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). 3. Capable to corporate with the study protocol and to sign an informed consent.
Exclusion criteria
1. Patients having received Botox treatment in the head region in the prior 4 months. 2. Patients having received supraorbital or occipital nerve blocks in the prior 4 months. 3. History of Medication Overuse Headache. 4. Patients using opioid medication. 5. 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). 6. Implanted metal or electrical devices in the head (not including dental implants). 7. Patient having had a previous experience with the Relievion™ device. 8. Patients who have concomitant epilepsy. 9. History of neurosurgical interventions. 10. Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps. 11. History of drug abuse or alcoholism. 12. Participation in current clinical study or participated in a clinical study within 3 months prior to this study. 13. Skin lesion or inflammation at the region of the stimulating electrodes. 14. Personality or somatoform disorder. 15. Pregnancy or Lactation. 16. Women with child bearing potential without medically acceptable method of contraception. 17. History of cerebrovascular event. 18. Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study). 19. Patients using Cannabis 20. Patients with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change of pain score (measured on a visual analog scale=VAS) at 1 hour compared to baseline | 1 hour | visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change of pain score (measured by VAS) at 2 hours compared to baseline (if rescue therapy was not used). | 2 hours | visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable painbaseline (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 | Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used). |
| Proportion of patients not having required rescue medication within 24 hours | 24 hours | Proportion of patients not having required rescue medication within 24 hours |
| 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 patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used). |
| 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). | 1, 2, 24 hours | visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain |
| Proportion of patients not having required rescue medication at 2 hours compared to baseline. | 2 hours | Proportion of patients not having required rescue medication at 2 hours |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoints will consist of recording of adverse events and serious adverse events during the study. Device related adverse events will be evaluated between study groups | 1, 2, 24 hours | Safety endpoints will consist of recording of adverse events and serious adverse events during the study. Device related adverse events will be evaluated between study groups |
Countries
Israel
Outcome results
None listed