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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
45
Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical
Mayo Clinic
Scottsdale, Arizona, United States
Neurology Research Institute
West Palm Beach, Florida, United States
Diamond Headache Clinic
Chicago, Illinois, United States
Change in Migraine Headache Days (MHD)
comparison of MHD recorded in baseline month versus 3rd month of treatment
Time frame: 1 month of baseline recordation followed by 84 days of device use
Normalized Reduction in Migraine Headache Days
comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo
Time frame: 1 month of baseline recordation followed by 84 days of device use
Change in Medication Usage
reduction in acute, prescribed medications in month 3 of treatment versus baseline month
Time frame: 1 month of baseline recordation followed by 84 days of device use
Change in Headache Pain
reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month
Time frame: 1 month of baseline recordation followed by 84 days of device use
Change in Quality of Life
comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3
Time frame: 1 month of baseline recordation followed by 84 days of device use
Change in Depression
comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3
Time frame: 1 month of baseline recordation followed by 84 days of device use
Change in Anxiety
comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3
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Michigan Headache Pain & Neurological Inst.
Ann Arbor, Michigan, United States
Study Metrix Research
City of Saint Peters, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cleveland Clinic
Cleveland, Ohio, United States
Jefferson Headache Center
Philadelphia, Pennsylvania, United States
King's College London
London, Denmark Hill, United Kingdom
University of Kent
Canterbury, Kent, United Kingdom
Time frame: 1 month of baseline recordation followed by 84 days of device use
Change in Sleep Quality
comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3
Time frame: 1 month of baseline recordation followed by 84 days of device use
Additional Treatment Time
comparison of MHD recorded in baseline month versus 6th month of treatment
Time frame: 1 month of baseline recordation followed by 168 days of device use
Sustained Reduction in Migraine Headache Days
comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9
Time frame: 1 month of baseline recordation followed by 252 days of device use