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Migraine Treatment With Nerivio Migra Neurostimulation Device

This study is currently recruiting participants.
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: May 30, 2017
Last verified: March 2017
March 7, 2017
May 30, 2017
April 2, 2017
December 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03076515 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Migraine Treatment With Nerivio Migra Neurostimulation Device
A Prospective, Randomized, Double-blind, Sham Controlled Multi-center Clinical Trial, Migraine Headache Treatment With Nerivio Migra Neurostimulation Device
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Acute Migraine
  • Device: Nerivio Migra neurostimulation
    transcutaneous electrical stimulation
  • Device: Sham Nerivio Migra
    electrical stimulation- shame mode
  • Active Comparator: Nerivio Migra active
    Intervention: Device: Nerivio Migra neurostimulation
  • Sham Comparator: Nerivio Migra placebo
    Intervention: Device: Sham Nerivio Migra
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
April 2018
December 2017   (Final data collection date for primary outcome measure)

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. -
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Solli Brawer, DVM 972723909755 sollib@theranica.com
Israel,   United States
 
 
NCT03076515
TCH_002
Yes
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
Plan to Share IPD: No
Theranica
Theranica
Not Provided
Principal Investigator: Brian M Grosberg, MD Hartford Healthcare Headache Center
Theranica
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP