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

NCT03631550 | Completed Results FDA Device

• 1 other identifier: SP-302 RIME
• Study Type: interventional
• Target: 187
• Locations: 2 countries
• Sites: 12

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®)

Conditions

Acute Migraine

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 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)

  2 hours from treatment initiation

Secondary Outcomes (3)

• 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

• Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation

  1 hour from treatment initiation

• Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation

  2 hours from treatment initiation

Other Outcomes (2)

• Number of Participants With Adverse Events

  From Enrollment (randomization) through study exit i.e. 70 days

• The Change in Pseudo-continuous Pain Score From Baseline to 1-hour Post Treatment

  baseline to 1-hour post treatment

Study Arms (2)

Active

ACTIVE COMPARATOR

Relivion Active device

Device: Relivion active

Sham

SHAM COMPARATOR

Relivion Sham device

Device: Relivion Sham

Interventions

Relivion active DEVICE

1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation

Active

Relivion Sham DEVICE

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

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurolief Ltd.: lead

Study Sites (12)

Clinical Research Consortium, an AMR company

Tempe, Arizona, 85283, United States

Location

Hartford HealthCare Headache Center

Hartford, Connecticut, 06107, United States

Location

Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

Regeneris Medical

North Attleboro, Massachusetts, 02760, United States

Location

Clinical Research Consortium, an AMR company

Las Vegas, Nevada, 89119, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Barzilai MC

Ashkelon, Israel

Location

Hillel Yaffe Medical Center

Hadera, Israel

Location

Sharei Zedek MC

Jerusalem, Israel

Location

Macabi healtcenter services

Kfar Saba, Israel

Location

Laniado MC

Netanya, Israel

Location

Macabi healtcenter services

Raanana, Israel

Location

Related Publications (1)

• 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.

  PMID: 35748757 DERIVED

Results Point of Contact

• Title: Michal Kedar-Datel
• Organization: Neurolief Ltd.

michal.kedar-datel@neurolief.com

+972-52-6659806

Study Officials

• stewart J. Tepper, Dr.

  Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: November 29, 2018
• Primary Completion: August 4, 2020
• Study Completion: August 4, 2020
• Last Updated: September 22, 2022
• Results First Posted: July 12, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (6); US (6)