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

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ClinicalTrials.gov Identifier: NCT02991430
Recruitment Status : Terminated (Inability to supply and maintain treatment device. No safety concerns occurred.)
First Posted : December 13, 2016
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Scion NeuroStim

Brief Summary:
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.

Condition or disease Intervention/treatment Phase
Intervention Device: active neuromodulation for episodic migraine headache Device: placebo neuromodulation for episodic migraine headache Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
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
Actual Study Start Date : June 30, 2017
Actual Primary Completion Date : May 11, 2018
Actual Study Completion Date : May 11, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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)

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): NCT02991430


Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Florida
Neurology Research Institute
West Palm Beach, Florida, United States, 33407
United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States, 60642
United States, Michigan
Michigan Headache Pain & Neurological Inst.
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Study Metrix Research
Saint Peters, Missouri, United States, 63303
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
United Kingdom
King's College London
London, Denmark Hill, United Kingdom, SE5 9PJ
University of Kent
Canterbury, Kent, United Kingdom, CT2 7NP
Sponsors and Collaborators
Scion NeuroStim

Responsible Party: Scion NeuroStim
ClinicalTrials.gov Identifier: NCT02991430     History of Changes
Other Study ID Numbers: SNS-MIG-02
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
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