A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
- Conditions
- Intervention
- Interventions
- Device: active neuromodulation for episodic migraine headacheDevice: placebo neuromodulation for episodic migraine headache
- Registration Number
- NCT02991430
- Lead Sponsor
- Scion NeuroStim
- Brief Summary
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 45
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description active active neuromodulation for episodic migraine headache active neuromodulation placebo placebo neuromodulation for episodic migraine headache placebo neuromodulation
- Primary Outcome Measures
Name Time Method Change in Migraine Headache Days (MHD) 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
Name Time Method Change in Medication Usage 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 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 Anxiety 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 Depression 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
Sustained Reduction in Migraine Headache Days 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
Normalized Reduction in Migraine Headache Days 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 Sleep Quality 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 1 month of baseline recordation followed by 168 days of device use comparison of MHD recorded in baseline month versus 6th month of treatment
Change in Quality of Life 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
Trial Locations
- Locations (10)
University of Kent
🇬🇧Canterbury, Kent, United Kingdom
King's College London
🇬🇧London, Denmark Hill, United Kingdom
Mayo Clinic
🇺🇸Scottsdale, Arizona, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Neurology Research Institute
🇺🇸West Palm Beach, Florida, United States
Diamond Headache Clinic
🇺🇸Chicago, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Jefferson Headache Center
🇺🇸Philadelphia, Pennsylvania, United States
Study Metrix Research
🇺🇸Saint Peters, Missouri, United States
Michigan Headache Pain & Neurological Inst.
🇺🇸Ann Arbor, Michigan, United States