Clinical trial NCT02991430: A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
Official title: A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intervention
Keywords: migraine headache, episodic
Lead sponsor: Scion NeuroStim
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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)

Primary outcomes:
measure: Change in Migraine Headache Days (MHD)
timeFrame: 1 month of baseline recordation followed by 84 days of device use
Secondary outcomes:
measure: Normalized Reduction in Migraine Headache Days
timeFrame: 1 month of baseline recordation followed by 84 days of device use
measure: Change in Medication Usage
timeFrame: 1 month of baseline recordation followed by 84 days of device use
measure: Change in Headache Pain
timeFrame: 1 month of baseline recordation followed by 84 days of device use
measure: Change in Quality of Life
timeFrame: 1 month of baseline recordation followed by 84 days of device use
measure: Change in Depression
timeFrame: 1 month of baseline recordation followed by 84 days of device use
measure: Change in Anxiety
timeFrame: 1 month of baseline recordation followed by 84 days of device use
measure: Change in Sleep Quality
timeFrame: 1 month of baseline recordation followed by 84 days of device use
measure: Additional Treatment Time
timeFrame: 1 month of baseline recordation followed by 168 days of device use
measure: Sustained Reduction in Migraine Headache Days
timeFrame: 1 month of baseline recordation followed by 252 days of device use
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: West Palm Beach
country: United States
facility: Neurology Research Institute
state: Florida
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: Ann Arbor
country: United States
facility: Michigan Headache Pain & Neurological Inst.
state: Michigan
city: Saint Peters
country: United States
facility: Study Metrix Research
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
city: London
country: United Kingdom
facility: King's College London
state: Denmark Hill
city: Canterbury
country: United Kingdom
facility: University of Kent
state: Kent
Study officials:
References: