Clinical trial NCT03631550: The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Official title: The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Migraine
Lead sponsor: Neurolief Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation
timeFrame: 2 hours from treatment initiation
Secondary outcomes:
measure: Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation
timeFrame: 2 hours from treatment initiation
measure: Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation
timeFrame: 1 hour from treatment initiation
measure: Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation
timeFrame: 2 hours from treatment initiation
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From Enrollment (randomization) through study exit i.e. 70 days
measure: The Change in Pseudo-continuous Pain Score From Baseline to 1-hour Post Treatment
timeFrame: baseline to 1-hour post treatment
Locations:
city: Tempe
country: United States
facility: Clinical Research Consortium, an AMR company
state: Arizona
city: Hartford
country: United States
facility: Hartford HealthCare Headache Center
state: Connecticut
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: North Attleboro
country: United States
facility: Regeneris Medical
state: Massachusetts
city: Las Vegas
country: United States
facility: Clinical Research Consortium, an AMR company
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Ashkelon
country: Israel
facility: Barzilai MC
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Jerusalem
country: Israel
facility: Sharei Zedek MC
city: Kfar Saba
country: Israel
facility: Macabi healtcenter services
city: Netanya
country: Israel
facility: Laniado MC
city: Ra'anana
country: Israel
facility: Macabi healtcenter services
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA
name: stewart J. Tepper, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.