Clinical trial NCT01899040: A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache
Official title: A Non-Invasive Neuromodulation Device for Treatment of Migraine Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Headache, Episodic
Keywords: neuromodulation
migraine headache
CVS
Lead sponsor: Scion NeuroStim
Sponsor class: INDUSTRY
First posted: 2013-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed with two arms - active and placebo. The devices for the first 20 placebo-randomized participants were found to be partially active. Therefore, the fully placebo arm was separated into placebo and partially active placebo. Only the active and placebo arms were followed (and outcomes posted) for effectiveness. All (active, placebo, and partially active) were followed and outcomes posted for safety.
Primary purpose: TREATMENT

Brief summary: This is a randomized, blinded study designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of episodic migraine headaches.

Detailed description: This is a multi-center, triple-blinded, placebo-controlled, randomized pivotal trial evaluating the adjunctive prophylactic treatment of episodic migraine headache using a caloric vestibular stimulation (CVS) device developed by Scion NeuroStim, LLC (SNS). This study has been reviewed by the FDA and is categorized as posing NSR (nonsignificant risk).

Eligibility criteria: INCLUSION CRITERIA:

* The patient must have been diagnosed with episodic Migraine Headache at least 6 months prior to entering into the Study, consistent with the International Headache Classification of Headache Disorders-II (ICHD-II) guidelines.
* The patient must have a history of at least three consecutive months of stable Migraine Headaches prior to entering the Study. The patients will not have had changes in medication usage for the three Months leading up to the Study, nor will they introduce new medications during the Study period. Patients will satisfy these criteria: On a Monthly basis, at least four, and not more than a total of fourteen (4-14), Headache Days (Pain Score between one and ten) of which between four and nine (4-14) are Migraine Headache Days
* The patient must not have failed on more than two classes of properly administered prophylactic pharmaceutical therapies for migraine headache. The patient may be on a single migraine prophylactic as long as the dosage has not been altered within 3 months of starting the study and the dosage must not be altered for the duration of the study.
* The Investigator must have confidence in the patient's ability to reliably use the Experimental Device and promptly complete the Daily Headache Diary forms. The Daily Headache Diary will be completed from the beginning of the Pre-Treatment Baseline Period through the end of the Pivotal Study.

EXCLUSION CRITERIA:

Individuals who:

* are pregnant
* have a history of cardiovascular disease
* work night shifts
* have been diagnosed with vestibular migraine
* have been diagnosed with migraine with aura
* have menstrual migraine exclusively
* have been diagnosed with post-traumatic migraine
* have a history of unstable mood disorder or unstable anxiety disorder
* use a hearing aid
* have a cochlear implant
* have chronic tinnitus
* have temporomandibular joint (TMJ) disease
* have been diagnosed with traumatic brain injury (TBI)
* have been diagnosed with neurological disease other than Headaches
* have a diagnosed vestibular dysfunction
* abuse alcohol or other drugs
* are experiencing medication overuse Headaches (individuals with respect to whom the Investigator is concerned that analgesic abuse is involved based on the ICHD-II guidelines).
* are younger than 18 years or older than 65 years
* have had eye surgery within the previous three months or ear surgery within the previous six months
* have active ear infections or a perforated tympanic membrane
* have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
* are using Botox treatments for migraines
* Though not excluded, patients taking anti-histamines or anti-nausea drugs will be encouraged not to take such medications within four hours prior to using the Device. The Investigator should review other medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these may reduce responsiveness to stimulation. Such medications should also be avoided within four hours prior to a treatment.

Primary outcomes:
measure: Change in Number of Monthly Migraine Headache Days
timeFrame: after 84 days of Device use
Secondary outcomes:
measure: Number of Monthly Migraine Headache Days (Reduction by by 50% or More)
timeFrame: after 84 days of Device use
measure: Total Monthly Headache Pain Score
timeFrame: after 84 days of Device use
measure: (Safety Measure) Mood and Cognition - Change in Beck Depression Index Score
timeFrame: after 84 days of Device use
measure: (Safety Measure) Dizziness: Verify the Absence of Change in Material Dizziness (Berg Balance)
timeFrame: after 84 days of Device use
measure: (Safety Measure) Mood and Cognition - Change in Digit Symbol Coding Cognitive Speed
timeFrame: after 84 days of Device use
measure: (Safety Measure) Mood and Cognition Measure - Change in Short Term Memory Test Scores
timeFrame: after 84 days of Device use
measure: Average of Monthly Treated Headaches (Acute Anti-migraine Prescription Drug Intake)
timeFrame: after 84 days of device use
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center
state: California
city: Ann Arbor
country: United States
facility: Michigan Headache and Neurological Institute
state: Michigan
city: Chapel Hill
country: United States
facility: Carolina Headache Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Canterbury
country: United Kingdom
facility: Kent University
state: Kent
Study officials:
affiliation: Scion NeuroStim
name: Lesco Rogers, MD
role: STUDY_DIRECTOR
References:
citation: Wilkinson D, Ade KK, Rogers LL, Attix DK, Kuchibhatla M, Slade MD, Smith LL, Poynter KP, Laskowitz DT, Freeman MC, Hoffer ME, Saper JR, Scott DL, Sakel M, Calhoun AH, Black RD. Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial. Headache. 2017 Jul;57(7):1065-1087. doi: 10.1111/head.13120. Epub 2017 Jun 27.