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Evaluation of a Novel Device for Treatment of Migraine Headache

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ClinicalTrials.gov Identifier: NCT03361423
Recruitment Status : Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : August 21, 2018
Sponsor:
Collaborators:
Rambam Health Care Campus
Northwell Health
Information provided by (Responsible Party):
Theranica

Brief Summary:

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, randomized, double blinded, sham controlled study
Masking: Double (Participant, Investigator)
Masking Description:

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

Primary Purpose: Treatment
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
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Percentage of reduction of migraine headache post 2 hours from 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).


Secondary Outcome Measures :
  1. Percentage of reduction of most bothersome migraine-associated symptom (MBS) relief post 2 hours 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

  2. Percentage of reduced Migraine Headache AND MBS Relief post 2 hours post tresatment [ 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

  3. Percentage of pain disappearance 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


Other Outcome Measures:
  1. Safety performance of the study device following treatment with study device: Rate of Adverse events related or unrelated to the study device [ Time Frame: 48 hours post migraine onset ]
    Rate of Adverse events related or unrelated to the study device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects age 18-75 years old.
  2. Subjects meet the ICHD-3 diagnostic criteria for migraine with or without aura
  3. Subjects report 2-8 migraine attacks per month.
  4. Stable migraine preventive medications in the last two months prior to recruitment (No change in usage or dosage).
  5. Subjects must be able and willing to comply with the protocol
  6. Subjects must be able and willing to provide written informed consent

Exclusion Criteria:

  1. Subject has other significant pain, medical or psychologic problems that in the opinion of the investigator may confound the study assessments
  2. Subject has an implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagus nerve neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator).
  3. Subject has known uncontrolled epilepsy.
  4. Any use of Cannabis including medical use.
  5. Subject has >10 headache days per month.
  6. Subject has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
  7. Subject is participating in any other clinical study.
  8. The subject does not have the basic cognitive and motor skills needed to operate a smartphone.
  9. Pregnant, or trying to get pregnant
  10. Subject is experiencing a menstrually related migraine
  11. Received OnabotulinumtoxinA or any botulinum toxin injections for migraine within the previous month
  12. Received parenteral infusions for migraine within the previous 2 weeks.
  13. Subject participated in a previous study with the Nerivio Migra 1 device

Information from the National Library of Medicine

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


Locations
United States, Connecticut
Hartford Headache Center
Hartford, Connecticut, United States, 06107
United States, Missouri
Mercy Hospital
Saint Louis, Missouri, United States, 63141
Clinvest Research
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
Israel
Rambam Medical Center
Haifa, Israel
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
Sponsors and Collaborators
Theranica
Rambam Health Care Campus
Northwell Health
Investigators
Study Director: David Yarnitsky, Prof Rambam Medical Center, Israel
Study Chair: Moris Levin, MD University California Sun Francisco, USA

Responsible Party: Theranica
ClinicalTrials.gov Identifier: NCT03361423     History of Changes
Other Study ID Numbers: TCH003
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases