Back to resultsThe RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Primary Purpose
Acute Migraine
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Relivion active
Relivion Sham
Sponsored by
About this trial
This is an interventional treatment trial for Acute Migraine
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.
Sites / Locations
- Clinical Research Consortium, an AMR company
- Hartford HealthCare Headache Center
- Yale School of Medicine
- Regeneris Medical
- Clinical Research Consortium, an AMR company
- Dartmouth-Hitchcock Medical Center
- Barzilai MC
- Hillel Yaffe Medical Center
- Sharei Zedek MC
- Macabi healtcenter services
- Laniado MC
- Macabi healtcenter services
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active
Sham
Arm Description
Relivion Active device
Relivion Sham device
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03631550
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
August 4, 2020 (Actual)
Study Completion Date
August 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurolief Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Relivion Active device
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Relivion Sham device
Intervention Type
Device
Intervention Name(s)
Relivion active
Intervention Description
1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation
Intervention Type
Device
Intervention Name(s)
Relivion Sham
Intervention Description
1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation
Primary Outcome Measure Information:
Title
Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation
Description
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)
Time Frame
2 hours from treatment initiation
Secondary Outcome Measure Information:
Title
Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation
Description
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
Time Frame
2 hours from treatment initiation
Title
Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation
Description
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
Time Frame
1 hour from treatment initiation
Title
Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation
Description
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
Time Frame
2 hours from treatment initiation
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Events
Description
Safety of the study device following study treatment: Number and Rate of participates with Adverse events related or unrelated to the study device
Time Frame
From Enrollment (randomization) through study exit i.e. 70 days
Title
The Change in Pseudo-continuous Pain Score From Baseline to 1-hour Post Treatment
Description
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.
Time Frame
baseline to 1-hour post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stewart J. Tepper, Dr.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Consortium, an AMR company
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Hartford HealthCare Headache Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06107
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Regeneris Medical
City
North Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02760
Country
United States
Facility Name
Clinical Research Consortium, an AMR company
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Barzilai MC
City
Ashkelon
Country
Israel
Facility Name
Hillel Yaffe Medical Center
City
Hadera
Country
Israel
Facility Name
Sharei Zedek MC
City
Jerusalem
Country
Israel
Facility Name
Macabi healtcenter services
City
Kfar Saba
Country
Israel
Facility Name
Laniado MC
City
Netanya
Country
Israel
Facility Name
Macabi healtcenter services
City
Ra'anana
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35748757
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.
Results Reference
derived
Learn more about this trial
The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
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