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Trial record 1 of 1 for:    NCT03076515
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Migraine Treatment With Nerivio Migra Neurostimulation Device

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2017 by Theranica
Sponsor:
Information provided by (Responsible Party):
Theranica
ClinicalTrials.gov Identifier:
NCT03076515
First received: March 7, 2017
Last updated: March 9, 2017
Last verified: March 2017
  Purpose
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 Intervention
Acute Migraine
Device: Nerivio Migra neurostimulation
Device: Sham Nerivio Migra

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Theranica:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 160
Anticipated Study Start Date: March 2017
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nerivio Migra active Device: Nerivio Migra neurostimulation
transcutaneous electrical stimulation
Sham Comparator: Nerivio Migra placebo Device: Sham Nerivio Migra

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03076515

Contacts
Contact: Solli Brawer, DVM sollib@theranica.com

Locations
United States, District of Columbia
MedStar - Georgetown University Hospital
Washington DC, District of Columbia, United States, 20007
United States, New York
Albany Medical College Not yet recruiting
Albany, New York, United States, 12208
Principal Investigator: Charles Argoff, MD         
Hartford Healthcare Headache Center Not yet recruiting
Hartford, New York, United States, 06103
Principal Investigator: Brian M Grosberg, MD         
Israel
Hillel Yaffe Medical Center
Hadera, Israel
Herzeliya medical Center
Herzliya, Israel
Maccabi Healthcare neurology clinics
Kefar Saba, Israel
Western Galilee Medical Center Not yet recruiting
Nahariya, Israel
Contact: Bella Gross, MD         
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
Study First Received: March 7, 2017
Last Updated: March 9, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 28, 2017