This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Scion NeuroStim
Sponsor:
Information provided by (Responsible Party):
Scion NeuroStim
ClinicalTrials.gov Identifier:
NCT02991430
First received: December 4, 2016
Last updated: August 8, 2017
Last verified: August 2017
  Purpose
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.

Condition Intervention
Intervention Device: active neuromodulation for episodic migraine headache Device: placebo neuromodulation for episodic migraine headache

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache

Resource links provided by NLM:


Further study details as provided by Scion NeuroStim:

Primary Outcome Measures:
  • change in migraine headache days (MHD) [ Time Frame: 1 month of baseline recordation followed by 84 days of device use ]
    comparison of MHD recorded in baseline month versus 3rd month of treatment


Secondary Outcome Measures:
  • normalized reduction in migraine headache days [ Time Frame: 1 month of baseline recordation followed by 84 days of device use ]
    comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo

  • change in medication usage [ Time Frame: 1 month of baseline recordation followed by 84 days of device use ]
    reduction in acute, prescribed medications in month 3 of treatment versus baseline month

  • change in headache pain [ Time Frame: 1 month of baseline recordation followed by 84 days of device use ]
    reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month

  • change in quality of life [ Time Frame: 1 month of baseline recordation followed by 84 days of device use ]
    comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3

  • change in depression [ Time Frame: 1 month of baseline recordation followed by 84 days of device use ]
    comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3

  • change in anxiety [ Time Frame: 1 month of baseline recordation followed by 84 days of device use ]
    comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3

  • change in sleep quality [ Time Frame: 1 month of baseline recordation followed by 84 days of device use ]
    comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3

  • additional treatment time [ Time Frame: 1 month of baseline recordation followed by 168 days of device use ]
    comparison of MHD recorded in baseline month versus 6th month of treatment

  • sustained reduction in migraine headache days [ Time Frame: 1 month of baseline recordation followed by 252 days of device use ]
    comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9


Estimated Enrollment: 120
Actual Study Start Date: June 30, 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active
active neuromodulation
Device: active neuromodulation for episodic migraine headache
Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
Placebo Comparator: placebo
placebo neuromodulation
Device: placebo neuromodulation for episodic migraine headache
Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical

Detailed Description:
This study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache (with or without aura) using neuromodulation device developed by Scion NeuroStim, LLC (SNS). The investigational use of the device for episodic migraine headache has been reviewed by the FDA and is classified as NSR (non-significant risk).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with episodic migraine at least 6 months before study
  • at least 3 consecutive months of stable migraine headaches before study
  • at least 4-14 headache days per month, of which 4-14 may be migraines
  • must not have failed on more than 2 classes of migraine preventatives

Exclusion Criteria:

  • previous use of the experimental device
  • pregnant
  • using more than 1 concurrent migraine preventive
  • history of cardiovascular disease
  • work night shifts
  • diagnosed with vestibular migraine
  • menstrual migraines exclusively
  • diagnosed with post-traumatic migraine
  • have a history of unstable mood or anxiety disorder
  • use a hearing aid
  • have a cochlear implant
  • have chronic tinnitus
  • have temporomandibular joint disease
  • diagnosed with traumatic brain injury
  • diagnosed with neurological disease other than headaches
  • diagnosed vestibular and/or balance dysfunction
  • history of abusing alcohol or other drugs
  • are experiencing medication overuse headaches
  • have had eye surgery in the previous 3 months
  • have had ear surgery in the previous 6 months
  • have active ear infections or a perforated tympanic membrane
  • have participated in another clinical trial in the last 30 days
  • are currently participating in another clinical trial
  • using Botulinum toxin-based treatments for migraines or cosmetic reasons
  • taking anti-emetics more than 2 times per week (consistently)
  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: NCT02991430

Contacts
Contact: Kathryn Poynter, RN, CCRP 336-907-5092 kpoynter@scionneurostim.com
Contact: Robert Black, Ph.D. 919-260-5528 rblack@scionneurostim.com

Locations
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Michaele Menghini    480-301-6651    menghini.michaele@mayo.edu   
Principal Investigator: Rashmi Halker-Singh, MD         
United States, Florida
Neurology Research Institute Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Ashley Poulette    561-845-0500 ext 134    ashpriresearch@aol.com   
Principal Investigator: Paul Winner, DO         
United States, Illinois
Diamond Headache Clinic Recruiting
Chicago, Illinois, United States, 60642
Contact: Elena Feoktistova    773-388-6383    efeoktistova@diamondheadache.com   
Principal Investigator: Merle Diamond, MD         
United States, Michigan
Michigan Headache Pain & Neurological Inst. Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Anita Severance    734-677-6000    aseverance@mhni.com   
Principal Investigator: Joel Saper, MD         
United States, Missouri
Study Metrix Research Recruiting
Saint Peters, Missouri, United States, 63303
Contact: Elizabeth Maryas    636-387-5100 ext 101    Emaryas@studymetrix.com   
Principal Investigator: Timothy Smith, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Julie Bursey, CCRP    603-653-9948    Julie.A.Bursey@hitchcock.org   
Principal Investigator: Stewart Tepper, MD         
United States, North Carolina
Carolina Headache Institute Recruiting
Durham, North Carolina, United States, 27713
Contact: Chris Pruitt    919-942-4424 ext 113    pruittc@chi09.com   
Principal Investigator: Anne Calhoun, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Michael Zeleny    216-445-1861    ZELENYM@ccf.org   
Principal Investigator: Zubair Ahmed, MD         
United States, Pennsylvania
Jefferson Headache Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kathleen Bradley    215-955-2025    kathleen.bradley@jefferson.edu   
Principal Investigator: Stephen Silberstein, MD         
United Kingdom
King's College London Recruiting
London, Denmark Hill, United Kingdom, SE5 9PJ
Contact: Jack Holland    +44 (0) 203 299 6384    jack.holland@kcl.ac.uk   
Principal Investigator: Peter Goadsby, MD         
University of Kent Recruiting
Canterbury, Kent, United Kingdom, CT2 7NP
Contact: Laura Smith, Ph.D.    +44 (0)1227 824772    ls480@kent.ac.uk   
Principal Investigator: David Wilkinson, Ph.D.         
Sponsors and Collaborators
Scion NeuroStim
  More Information

Responsible Party: Scion NeuroStim
ClinicalTrials.gov Identifier: NCT02991430     History of Changes
Other Study ID Numbers: SNS-MIG-02
Study First Received: December 4, 2016
Last Updated: August 8, 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

Keywords provided by Scion NeuroStim:
migraine headache, episodic

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2017