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Migraine Treatment With Nerivio Migra Neurostimulation Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03076515
Recruitment Status : Active, not recruiting
First Posted : March 10, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Acute Migraine Device: Nerivio Migra neurostimulation Device: Sham Nerivio Migra

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind, Sham Controlled Multi-center Clinical Trial, Migraine Headache Treatment With Nerivio Migra Neurostimulation Device
Actual Study Start Date : April 2, 2017
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Nerivio Migra active Device: Nerivio Migra neurostimulation
transcutaneous electrical stimulation
Sham Comparator: Nerivio Migra placebo Device: Sham Nerivio Migra
electrical stimulation- shame mode


Outcome Measures

Primary Outcome Measures :
  1. pain relief [ Time Frame: 2 hours post treatment ]
    Percentage of patients reporting freedom from pain (pain grade 0) 2 hours post treatment without rescue medications in at least 50% of treated attacks


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patient is 18-75 years old.
  2. Patient meeting the ICHD-3 diagnostic criteria for migraine with and without aura.
  3. Patients reporting 2-8 migraine attacks per month.
  4. Patient must be able and willing to comply with the protocol.
  5. Patient must be able and willing to provide written informed consent.
  6. Male or non-pregnant / non-lactating female (NOTE: Females of child bearing potential must have a negative pregnancy test) and must be willing to use adequate contraceptive means during the study

Exclusion Criteria:

  1. Has other significant pain problem that in the opinion of the investigator may confound the study assessments
  2. Is currently implanted with an 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. Known uncontrolled epilepsy.
  4. Use of Cannabis including medical use.
  5. Has chronic migraine (more than 15 headache days per month).
  6. Changed usage or dosage of migraine preventive medications in the last two months
  7. Has undergone nerve block (occipital or other) in the head or neck within the last 2 weeks.
  8. Is participating in any other clinical study. -
Contacts and Locations

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): NCT03076515


Locations
United States, District of Columbia
MedStar - Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Hartford Healthcare Headache Center
Hartford, New York, United States, 06103
Northwell Health, Inc
New York, New York, United States, 11042
Israel
Hillel Yaffe Medical Center
Hadera, Israel
Herzeliya medical Center
Herzliya, Israel
Maccabi Healthcare neurology clinics
Kefar Saba, Israel
Western Galilee Medical Center
Nahariya, Israel
Sponsors and Collaborators
Theranica
Investigators
Principal Investigator: Brian M Grosberg, MD Hartford Healthcare Headache Center
More Information

Responsible Party: Theranica
ClinicalTrials.gov Identifier: NCT03076515     History of Changes
Other Study ID Numbers: TCH_002
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases