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

Neurolief

Status: Completed

Conditions: Acute Migraine

Treatments: Device: Relivion active; Device: Relivion Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT03631550

SP-302 RIME

Details and patient eligibility

About

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®)

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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187 participants in 2 patient groups

Active

Active Comparator group

Description:

Relivion Active device

Treatment:

Device: Relivion active

Sham

Sham Comparator group

Description:

Relivion Sham device

Treatment:

Device: Relivion Sham