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

NCT ID: NCT03631550

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2020-08-04

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.

Conditions

Acute Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active

Relivion Active device

Group Type: ACTIVE_COMPARATOR

Relivion active

Intervention Type: DEVICE

1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation

Sham

Relivion Sham device

Group Type: SHAM_COMPARATOR

Relivion Sham

Intervention Type: DEVICE

1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation

Interventions

Relivion active

1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation

Intervention Type: DEVICE

Relivion Sham

1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects 18 years of age and older.

2. Subject meets the ICHD (International Classification of Headache Disorders)-3 (2018) diagnostic criteria for Migraine with or without aura.

3. Subject reports 1-6 Migraine attacks per month; other headaches no more than 6 days per month.

4. 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

1. Subject having received Botox treatment in the head region in the prior 3 months.

2. Subject having received supraorbital or occipital nerve blocks in the prior month.

3. Past 6 months of chronic migraine, New Daily Persistent Headache, and chronic tension-type headache per ICHD-3 (2018) diagnostic criteria.

4. Current medication overuse headache.

5. Use of opioid medications in the prior 1 month.

6. Use of barbiturates in the prior 1 month.

7. Subject has >10 headache days per month

8. Implanted metal/shrapnel or electrical devices in the head (not including dental implants), a cardiac pacemaker or an implanted or wearable defibrillator.

9. Received parenteral infusions for migraine within the previous 2 weeks.

10. Subject has known uncontrolled epilepsy.

11. History of neurosurgical interventions

12. Subject with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.

13. Current drug abuse or alcoholism.

14. Subject is participating in any other clinical study.

15. Skin lesion or inflammation at the region of the stimulating electrodes.

16. Personality or somatoform disorder.

17. Pregnancy or Lactation.

18. Women with child bearing potential without medically acceptable method of contraception (NOTE: Females of child bearing potential must have a negative pregnancy test).

19. Documented history of cerebrovascular event.

20. Subject with recent brain or facial trauma (occurred less than 3 months prior to this study).

21. Subject participated in a previous study with the Relivion device.

22. The subject does not have the basic cognitive and motor skills needed to operate a smartphone.

23. Subject with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters

24. Subject with other significant pain problem that in the opinion of the investigator may confound the study assessments.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurolief Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

stewart J. Tepper, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA

Locations

Clinical Research Consortium, an AMR company

Tempe, Arizona, 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

Clinical Research Consortium, an AMR company

Las Vegas, Nevada, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Barzilai MC

Ashkelon, , Israel

Hillel Yaffe Medical Center

Hadera, , Israel

Sharei Zedek MC

Jerusalem, , Israel

Macabi healtcenter services

Kfar Saba, , Israel

Laniado MC

Netanya, , Israel

Macabi healtcenter services

Raanana, , Israel

Countries

United States; Israel

References

Tepper SJ, Grosberg B, Daniel O, Kuruvilla DE, Vainstein G, Deutsch L, Sharon R. Migraine treatment with external concurrent occipital and trigeminal neurostimulation-A randomized controlled trial. Headache. 2022 Sep;62(8):989-1001. doi: 10.1111/head.14350. Epub 2022 Jun 24.

Reference Type: DERIVED

PMID: 35748757 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SP-302 RIME

Identifier Type: -

Identifier Source: org_study_id