N/A
N=187
The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Acute Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03631550 ↗Enrolled (actual)
187
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation — 30; 22 Participants — p=0.018
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Relivion active (Device); Relivion Sham (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Neurolief Ltd.
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation |
30; 22 | 0.018 sig |
| SECONDARY Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation |
29; 27 | 0.0466 sig |
| SECONDARY Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation |
21; 15 | 0.0677 |
| SECONDARY Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation |
23; 7 | <.0001 sig |
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®)
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- Personality or somatoform disorder.
- Pregnancy or Lactation.
- Women with child bearing potential without medically acceptable method of contraception (NOTE: Females of child bearing potential must have a negative pregnancy test).
- Documented history of cerebrovascular event.
- Subject with recent brain or facial trauma (occurred less than 3 months prior to this study).
- Subject participated in a previous study with the Relivion device.
- The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
- Subject with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters
- Subject with other significant pain problem that in the opinion of the investigator may confound the study assessments.
Data sourced from ClinicalTrials.gov (NCT03631550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.