Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of 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: Completed
• Conditions: Migraine
• Intervention / Treatment: Device: Relievion device- Treatment stimulation; Device: Relievion Device- Sham stimulation

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Netanya, Israel
    • Laniado Medcial Center

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• 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: 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
Mean change of pain score (measured on a visual analog scale=VAS) at 1 hour compared to baseline	visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of pain score (measured by VAS) at 2 hours compared to baseline (if rescue therapy was not used).	visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable painbaseline (if rescue therapy was not used).	2 hours
Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used).	Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used).	24 hours
Proportion of patients not having required rescue medication within 24 hours	Proportion of patients not having required rescue medication within 24 hours	24 hours
Proportion of patients not having required rescue medication at 2 hours compared to baseline.	Proportion of patients not having required rescue medication at 2 hours	2 hours
Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used).	Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used).	1, 2, 24 hours
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).	visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain	1, 2, 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1, 2, 24 hours

Collaborators and Investigators

• Sponsor: Neurolief Ltd.
• Investigators: Principal Investigator: Daniel Dr. Oved, Dr., Laniado Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2018
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (ACTUAL): January 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

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: SP301

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