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

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

Detailed Description
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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).

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

Conditions
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Intervention

Intervention / Treatment
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* Device: active neuromodulation for episodic migraine headache
* Device: placebo neuromodulation for episodic migraine headache


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active<br>active neuromodulation | Device: active neuromodulation for episodic migraine headache<br>* Non-invasive brainstem neuromodulator. Active and placebo devices appear identical<br>|
| Placebo Comparator: placebo<br>placebo neuromodulation | Device: placebo neuromodulation for episodic migraine headache<br>* Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Migraine Headache Days (MHD) | comparison of MHD recorded in baseline month versus 3rd month of treatment | 1 month of baseline recordation followed by 84 days of device use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalized Reduction in Migraine Headache Days | comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 1 month of baseline recordation followed by 252 days of device use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine headache, episodic