Evaluation of a Novel Device for Treatment of Migraine Headache
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|ClinicalTrials.gov Identifier: NCT03361423|
Recruitment Status : Completed
First Posted : December 4, 2017
Results First Posted : May 19, 2021
Last Update Posted : May 19, 2021
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment.
Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches including migraine. It is tolerable by patients and associated with no adverse effects.
The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere.
This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.
The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra electro stimulation device for the reduction of migraine headache during an attack of migraine with or without aura.
The study is intended for subject with 2-8 migraine episodes per month. patients will receive the device, either an active or a placebo type, and will be asked to use the device at home or in any location that they will be when the migraine starts.
The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral nervous system at onset of a migraine attack significantly reduce headache pain demonstrated by a significant difference between proportions of responders to the active treatment stimulation in comparison to proportion of responders that will use a placebo device.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Without Aura Migraine With Aura||Device: Nerivio Migra-1 active device Device: Nerivio Migra-1 Sham device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||296 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A prospective, randomized, double blinded, sham controlled study|
|Masking:||Double (Participant, Investigator)|
For sham control, electrical pulses of similar width and intensity, but much lower frequency compared to the active device will be administered. This sham program produces pulses that are perceivable by the user, thus maintaining the blinding, but on the other hand do not have therapeutic qualities.
The devices will be delivered with an identifying number, without exposing to the investigator or participant if it is an active or a pacebo/sham device
|Official Title:||A Randomized, Double Blinded, Sham Controlled Clinical Study to Evaluate the Safety and Efficacy of the Nerivio Migra 1, a Neuromodulation Device, for the Acute Treatment of Migraine|
|Actual Study Start Date :||December 17, 2017|
|Actual Primary Completion Date :||November 25, 2018|
|Actual Study Completion Date :||December 25, 2018|
Active Comparator: treatment of migraine with active device
Treatment of acute migraine with an active form of Nerivio migra-1 device
Device: Nerivio Migra-1 active device
The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as "pain inhibits pain" principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site.
Sham Comparator: treatment of migraine with sham device
Treatment of acute migraine with a sham form of the Nerivio Migra-1 device
Device: Nerivio Migra-1 Sham device
The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
- Percentage of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment [ Time Frame: 2 hours post migraine onset ]The percentage of patients reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their first treated migraine attack (excluding the "run-in test" treatment).
- Percentage of Participants With Reduction of Most Bothersome Migraine-associated Symptom (MBS) Relief at 2 Hours Post Treatment [ Time Frame: 2 hours post migraine onset ]The percentage of patients reporting, 2 hours post-treatment, freedom from their most bothersome migraine-associated symptom (MBS) other than a headache, in their first treated migraine attack (excluding the "run-in test" treatment). MBS may be nausea, photophobia, phonophobia or allodynia - as defined by each subject at the beginning of the treatment
- Percentage of Participants With Reduced Migraine Headache AND MBS Relief at 2 Hours Post Treatment [ Time Frame: 2 hours post migraine onset ]The percentage of patients reporting, 2 hours post treatment response to both the primary and the first secondary endpoints
- Percentage of Participants With Pain Disappearance at 2 Hours Post Treatment [ Time Frame: 2 hours post migraine onset ]The percentage of subjects reporting freedom from migraine pain at 2 hours post-treatment without medications in their first treated migraine attack
- Number of Adverse Events Related or Unrelated to the Study Device [ Time Frame: up to 14 weeks ]The number of Adverse events related to the study device. Safety analyses were performed on all participants from the ITT population (126 participants in each group).
- Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their Treatments [ Time Frame: up to 6 weeks ]The repeatability of migraine headache reduction, as described in the primary endpoint definition, in subsequent treated attacks. Thus, this endpoint measures the % of patient responding to the primary endpoint in at least 50% of their treated attacks (excluding the run-in attack
- Percentage of Participants With Sustained Pain-free 48 Hours With Single Use of the Device [ Time Frame: 48 hours post treatment ]The proportion (%) of subjects reporting pain-free at 2 hours, and no return of any pain or use of rescue/acute medication, or reuse of device between 2 hours and 48 hours, in their first treated migraine attack
- Percentage of Participants With Sustained Headache Reduction for 48 Hours With Single Use of the Device [ Time Frame: 48 hours post treatment ]The proportion (%) of subjects reporting treatment response 2 hours post-treatment without rescue medications, and no return to baseline level of pain at time of treatment, or use of rescue/acute medication, or reuse of device between 2 hours and 48 hours, in their first treated migraine attack
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361423
|United States, Connecticut|
|Hartford Headache Center|
|Hartford, Connecticut, United States, 06107|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63141|
|Springfield, Missouri, United States, 65810|
|United States, Nevada|
|Clinical Reseach Consortium|
|Las Vegas, Nevada, United States, 89119|
|United States, New York|
|Northwell Health, Inc|
|New York, New York, United States, 11042|
|Rochester Clinical Research|
|Rochester, New York, United States, 14609|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Rambam Medical Center|
|wolfson Medical Center|
|H̱olon, Israel, 58100|
|Meir Medical Center|
|Kfar Saba, Israel, 4428164|
|Belinson Medical Center|
|Petah Tikva, Israel, 4941492|
|Souraskyr Medical center - Ichilov|
|Tel Aviv, Israel|
|Study Director:||David Yarnitsky, Prof||Rambam Medical Center, Israel|
|Study Chair:||Moris Levin, MD||University California Sun Francisco, USA|