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

Acute Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03631550
• Other study ID #: SP-302 RIME
• Status: Completed
• Phase: N/A
• Start date: November 29, 2018
• Est. completion date: August 4, 2020

Study information

• Verified date: September 2022
• Source: Neurolief Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®)

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 information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: August 4, 2020
• Est. primary completion date: August 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Migraine
• Migraine Disorders

Intervention

Device:
• Relivion active
1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation
• Relivion Sham
1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation

Locations

Country	Name	City	State
Israel	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	Ra'anana
United States	Hartford HealthCare Headache Center	Hartford	Connecticut
United States	Clinical Research Consortium, an AMR company	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Yale School of Medicine	New Haven	Connecticut
United States	Regeneris Medical	North Attleboro	Massachusetts
United States	Clinical Research Consortium, an AMR company	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Neurolief Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Adverse Events	Safety of the study device following study treatment: Number and Rate of participates with Adverse events related or unrelated to the study device	From Enrollment (randomization) through study exit i.e. 70 days
Other	The Change in Pseudo-continuous Pain Score From Baseline to 1-hour Post Treatment	as per the Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency" June 2020 FDA Guidance, which states that a modifications to the definition and ascertainment of trial endpoints may be warranted to address the impact of COVID-19. A potential modification for a binary endpoint that is based on a continuous or ordinal measurement is by using the continuous or ordinal measurement as the endpoint. therefore, an additional analysis to the study end points , the migraine headache pain level was transformed into a numerical score (pseudo-continuous): "No pain"=0, "Mild"=1, "Moderate"=2, "Severe"=3. If rescue medication was used, the score after the rescue intake post-treatment are set to the baseline value. The change from baseline is compared between the study arms with an analysis of covariance model adjusted for site and baseline pain level.	baseline to 1-hour post treatment
Primary	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	Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-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	2 hours from treatment initiation
Secondary	Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post 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	1 hour from treatment initiation
Secondary	Proportion of Subjects Who Are Pain Free at 2 Hours Post 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	2 hours from treatment initiation