Clinical trial NCT03398668: Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Official title: Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Neurolief Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-12
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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™).


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change of pain score (measured on a visual analog scale=VAS) at 1 hour compared to baseline
timeFrame: 1 hour
Secondary outcomes:
measure: Mean change of pain score (measured by VAS) at 2 hours compared to baseline (if rescue therapy was not used).
timeFrame: 2 hours
measure: Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used).
timeFrame: 24 hours
measure: Proportion of patients not having required rescue medication within 24 hours
timeFrame: 24 hours
measure: Proportion of patients not having required rescue medication at 2 hours compared to baseline.
timeFrame: 2 hours
measure: Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used).
timeFrame: 1, 2, 24 hours
measure: 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).
timeFrame: 1, 2, 24 hours
Other outcomes:
measure: 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
timeFrame: 1, 2, 24 hours
Locations:
city: Netanya
country: Israel
facility: Laniado Medcial Center
Study officials:
affiliation: Laniado Medical center
name: Daniel Dr. Oved, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daniel O, Tepper SJ, Deutsch L, Sharon R. External Concurrent Occipital and Trigeminal Neurostimulation Relieves Migraine Headache: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial. Pain Ther. 2022 Sep;11(3):907-922. doi: 10.1007/s40122-022-00394-w. Epub 2022 Jun 4.