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

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.

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™).

Study Overview

• Status: Terminated
• Conditions: Migraine
• Intervention / Treatment: Device: Relievion Device- Sham stimulation; Device: Relievion Device- Treatment Stimulation

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Relievion device- Treatment stimulation; Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation	Device: Relievion Device- Treatment Stimulation; 1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation; Other Names: Neurolief device
Sham Comparator: Relievion device- Sham Stimulation; Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation	Device: Relievion Device- Sham stimulation; 1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation; Other Names: Sham Neurolief device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analogue Scale (VAS) Change from basline to 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)	1 Hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain VAS change from baseline to 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).	30 minutes
Pain VAS change from baseline to 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).	2 Hours
Pain VAS change from baseline to 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).	24 Hours
Pain VAS change from baseline to 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).	48 Hours
Rescue medication at 2 hours	Proportion of patients not having required rescue medication at 2 hours	2 hours
Rescue medication within 24 hours	Proportion of patients not having required rescue medication within 24 hours	24 hours
Rescue medication within 48 hours	Proportion of patients not having required rescue medication within 48 hours	48 hours

Collaborators and Investigators

• Sponsor: Neurolief Ltd.
• Investigators: Principal Investigator: Colin Klein, Dr, Meir Medical Center, Kfar Saba, Israel

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2017
• Primary Completion (Actual): January 9, 2018
• Study Completion (Actual): January 9, 2018

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 11, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 27, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: NRLF-0038-17-MMC-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No