Back to resultsA Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.
Primary Purpose
Migraine
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Relievion Device- Treatment Stimulation
Relievion Device- Sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III (International Classification of Headache Disorders) beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
- Capable of cooperating with the study protocol and to sign an informed consent.
Exclusion Criteria:
- Patients having received Botox treatment in the head region in the prior 4 months.
- Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
- History of Medication Overuse Headache.
- Patients using opioid medication.
- Allodynia: intolerance to supraorbital and/or occipital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 3 minutes of neurostimulation).
- Implanted metal or electrical devices in the head (not including dental implants).
- Patient having had a previous experience with the Relievion™ device.
- Patients who have concomitant epilepsy.
- History of neurosurgical interventions.
- Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
- History of drug abuse or alcoholism.
- Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
- Skin lesion or inflammation at the region of the stimulating electrodes.
- Personality or somatoform disorder.
- Pregnancy or Lactation.
- Women of reproductive age not using efficient contraceptive method.
- History of cerebrovascular event.
- Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
Sites / Locations
- Meir General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Relievion device- Treatment stimulation
Relievion device- Sham Stimulation
Arm Description
Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation
Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation
Outcomes
Primary Outcome Measures
Pain Visual Analogue Scale (VAS) Change from basline to 1 hour
Mean change of pain score (measured on a visual analog scale) at 1 hour compared to baseline (if rescue therapy was not used)
Secondary Outcome Measures
Pain VAS change from baseline to 30 minutes
Mean change of pain score (measured on a visual analog scale) at 30 minutes compared to baseline (if rescue therapy was not used).
Pain VAS change from baseline to 2 hours
Mean change of pain score (measured on a visual analog scale) at 2 hours compared to baseline (if rescue therapy was not used).
Pain VAS change from baseline to 24 hours
Mean change of pain score (measured on a visual analog scale) at 24 hours compared to baseline (if rescue therapy was not used).
Pain VAS change from baseline to 48 hours
Mean change of pain score (measured on a visual analog scale) at 48 hours compared to baseline (if rescue therapy was not used).
Rescue medication at 2 hours
Proportion of patients not having required rescue medication at 2 hours
Rescue medication within 24 hours
Proportion of patients not having required rescue medication within 24 hours
Rescue medication within 48 hours
Proportion of patients not having required rescue medication within 48 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03185559
Brief Title
A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.
Official Title
A Prospective, Randomized, Double-blind, Parallel-group, Sham Controlled Single-center Pivotal Clinical Investigation to Evaluate the Clinical Safety and Performance of Self-administered Home-use Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation Device (Relievion™) in Treating Migraine.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Investigator retierment
Study Start Date
July 23, 2017 (Actual)
Primary Completion Date
January 9, 2018 (Actual)
Study Completion Date
January 9, 2018 (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
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, Relievion™).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relievion device- Treatment stimulation
Arm Type
Active Comparator
Arm Description
Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation
Arm Title
Relievion device- Sham Stimulation
Arm Type
Sham Comparator
Arm Description
Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation
Intervention Type
Device
Intervention Name(s)
Relievion Device- Treatment Stimulation
Other Intervention Name(s)
Neurolief device
Intervention Description
1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation
Intervention Type
Device
Intervention Name(s)
Relievion Device- Sham stimulation
Other Intervention Name(s)
Sham Neurolief device
Intervention Description
1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation
Primary Outcome Measure Information:
Title
Pain Visual Analogue Scale (VAS) Change from basline to 1 hour
Description
Mean change of pain score (measured on a visual analog scale) at 1 hour compared to baseline (if rescue therapy was not used)
Time Frame
1 Hour
Secondary Outcome Measure Information:
Title
Pain VAS change from baseline to 30 minutes
Description
Mean change of pain score (measured on a visual analog scale) at 30 minutes compared to baseline (if rescue therapy was not used).
Time Frame
30 minutes
Title
Pain VAS change from baseline to 2 hours
Description
Mean change of pain score (measured on a visual analog scale) at 2 hours compared to baseline (if rescue therapy was not used).
Time Frame
2 Hours
Title
Pain VAS change from baseline to 24 hours
Description
Mean change of pain score (measured on a visual analog scale) at 24 hours compared to baseline (if rescue therapy was not used).
Time Frame
24 Hours
Title
Pain VAS change from baseline to 48 hours
Description
Mean change of pain score (measured on a visual analog scale) at 48 hours compared to baseline (if rescue therapy was not used).
Time Frame
48 Hours
Title
Rescue medication at 2 hours
Description
Proportion of patients not having required rescue medication at 2 hours
Time Frame
2 hours
Title
Rescue medication within 24 hours
Description
Proportion of patients not having required rescue medication within 24 hours
Time Frame
24 hours
Title
Rescue medication within 48 hours
Description
Proportion of patients not having required rescue medication within 48 hours
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III (International Classification of Headache Disorders) beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
Capable of cooperating with the study protocol and to sign an informed consent.
Exclusion Criteria:
Patients having received Botox treatment in the head region in the prior 4 months.
Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
History of Medication Overuse Headache.
Patients using opioid medication.
Allodynia: intolerance to supraorbital and/or occipital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 3 minutes of neurostimulation).
Implanted metal or electrical devices in the head (not including dental implants).
Patient having had a previous experience with the Relievion™ device.
Patients who have concomitant epilepsy.
History of neurosurgical interventions.
Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
History of drug abuse or alcoholism.
Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
Skin lesion or inflammation at the region of the stimulating electrodes.
Personality or somatoform disorder.
Pregnancy or Lactation.
Women of reproductive age not using efficient contraceptive method.
History of cerebrovascular event.
Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Klein, Dr
Organizational Affiliation
Meir Medical Center, Kfar Saba, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir General Hospital
City
Kfar Saba
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.
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