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

This study is currently recruiting participants.
Verified October 2017 by Scion NeuroStim
Sponsor:
ClinicalTrials.gov Identifier:
NCT02991430
First Posted: December 13, 2016
Last Update Posted: October 31, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Scion NeuroStim
December 4, 2016
December 13, 2016
October 31, 2017
June 30, 2017
July 2018   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT02991430 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.
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).
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intervention
  • Device: active neuromodulation for episodic migraine headache
    Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
  • Device: placebo neuromodulation for episodic migraine headache
    Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical
  • Active Comparator: active
    active neuromodulation
    Intervention: Device: active neuromodulation for episodic migraine headache
  • Placebo Comparator: placebo
    placebo neuromodulation
    Intervention: Device: placebo neuromodulation for episodic migraine headache
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2018
July 2018   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: Kathryn Poynter, RN, CCRP 336-907-5092 kpoynter@scionneurostim.com
Contact: Robert Black, Ph.D. 919-260-5528 rblack@scionneurostim.com
United Kingdom,   United States
 
 
NCT02991430
SNS-MIG-02
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
Plan to Share IPD: No
Scion NeuroStim
Scion NeuroStim
Not Provided
Not Provided
Scion NeuroStim
October 2017

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