The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

Not Applicable

Completed

Conditions: Acute Migraine

Interventions: Device: Relivion active
Device: Relivion Sham

Registration Number: NCT03631550

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, Relivion®)

Detailed Description: The Relivion® is a non-invasive transcutaneous neuro-stimulator is indicated for the acute treatment of migraine with or without aura in subjects 18 years of age or older. The Relivion® is intended to be a prescription device, self-used at home.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 187

Inclusion Criteria

Subjects 18 years of age and older.
Subject meets the ICHD (International Classification of Headache Disorders)-3 (2018) diagnostic criteria for Migraine with or without aura.
Subject reports 1-6 Migraine attacks per month; other headaches no more than 6 days per month.
Subject is willing to and capable of complying with the specified study requirements, provided written Informed Consent, can complete the electronic diaries, and can be contacted by telephone.

Exclusion Criteria

Subject having received Botox treatment in the head region in the prior 3 months.
Subject having received supraorbital or occipital nerve blocks in the prior month.
Past 6 months of chronic migraine, New Daily Persistent Headache, and chronic tension-type headache per ICHD-3 (2018) diagnostic criteria.
Current medication overuse headache.
Use of opioid medications in the prior 1 month.
Use of barbiturates in the prior 1 month.
Subject has >10 headache days per month
Implanted metal/shrapnel or electrical devices in the head (not including dental implants), a cardiac pacemaker or an implanted or wearable defibrillator.
Received parenteral infusions for migraine within the previous 2 weeks.
Subject has known uncontrolled epilepsy.
History of neurosurgical interventions
Subject with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
Current drug abuse or alcoholism.
Subject is participating in any other clinical study.
Skin lesion or inflammation at the region of the stimulating electrodes.
Personality or somatoform disorder.
Pregnancy or Lactation.
Women with child bearing potential without medically acceptable method of contraception (NOTE: Females of child bearing potential must have a negative pregnancy test).
Documented history of cerebrovascular event.
Subject with recent brain or facial trauma (occurred less than 3 months prior to this study).
Subject participated in a previous study with the Relivion device.
The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
Subject with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters
Subject with other significant pain problem that in the opinion of the investigator may confound the study assessments.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Relivion active	Relivion Active device
Sham	Relivion Sham	Relivion Sham device

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation	2 hours from treatment initiation	the number and percent of subjects reporting reduction of migraine headache pain 2 hours post treatment initiation from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack (if rescue therapy was not used)

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation	2 hours from treatment initiation	The number and percentage of subjects who are pain free at 2 hours post treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack
Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation	1 hour from treatment initiation	The number and percentage of subjects reporting reduction of migraine headache pain 1-hour post treatment initiation (if rescue therapy was not used), from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack
Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation	2 hours from treatment initiation	The number and percentage of subjects reporting improvement in their Most Bothersome Symptom (MBS) other than a headache, 2 hours post-treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack. MBS may be nausea, photophobia, phonophobia

Trial Locations

Locations (10): Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Clinical Research Consortium, an AMR company
🇺🇸
Las Vegas, Nevada, United States
Hartford HealthCare Headache Center
🇺🇸
Hartford, Connecticut, United States
Yale School of Medicine
🇺🇸
New Haven, Connecticut, United States
Regeneris Medical
🇺🇸
North Attleboro, Massachusetts, United States
Barzilai MC
🇮🇱
Ashkelon, Israel
Sharei Zedek MC
🇮🇱
Jerusalem, Israel
Macabi healtcenter services
🇮🇱
Ra'anana, Israel
Hillel Yaffe Medical Center
🇮🇱
Hadera, Israel
Laniado MC
🇮🇱
Netanya, Israel