A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.

Not Applicable

Terminated

• Conditions: Migraine
• Interventions: Device: Relievion Device- Treatment Stimulation; Device: Relievion Device- Sham stimulation

• Registration Number: NCT03185559
• Lead Sponsor: Neurolief Ltd.

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™).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-11
• Study First Submitted QC: 2017-06-11
• Study First Posted: 2017-06-14
• Study Start: 2017-07-23
• Primary Completion: 2018-01-09
• Study Completion: 2018-01-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relievion device- Treatment stimulation	Relievion Device- Treatment Stimulation	Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation
Relievion device- Sham Stimulation	Relievion Device- Sham stimulation	Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).
Rescue medication at 2 hours	2 hours	Proportion of patients not having required rescue medication at 2 hours
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

Trial Locations

Locations (1)

Meir General Hospital; 🇮🇱 Kfar Saba, Israel