Clinical trial NCT03185559: A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Migraine
Lead sponsor: Neurolief Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-14
Enrollment: 8
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:

* 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).

Primary outcomes:
measure: Pain Visual Analogue Scale (VAS) Change from basline to 1 hour
timeFrame: 1 Hour
Secondary outcomes:
measure: Pain VAS change from baseline to 30 minutes
timeFrame: 30 minutes
measure: Pain VAS change from baseline to 2 hours
timeFrame: 2 Hours
measure: Pain VAS change from baseline to 24 hours
timeFrame: 24 Hours
measure: Pain VAS change from baseline to 48 hours
timeFrame: 48 Hours
measure: Rescue medication at 2 hours
timeFrame: 2 hours
measure: Rescue medication within 24 hours
timeFrame: 24 hours
measure: Rescue medication within 48 hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir General Hospital
Study officials:
affiliation: Meir Medical Center, Kfar Saba, Israel
name: Colin Klein, Dr
role: PRINCIPAL_INVESTIGATOR
References: