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Objective
To evaluate the safety and efficacy of a novel solid-state, caloric vestibular stimulation (CVS) device to provide adjuvant therapy for the prevention of episodic migraine in adult migraineurs.
Headache: The Journal of Head and Face Pain
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Research Submissions
Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial
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Study Funding: This study was funded by Scion NeuroStim, LLC, USA.
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Study Registration: clinicaltrials.gov: NCT01899040.
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Conflict of Interest: D. Wilkinson, D.K. Attix, D.T. Laskowitz, M.E. Hoffer, and D.L. Scott report no disclosures. K.K. Ade and K. Poynter report receiving compensation and ownership interests, and L.L. Rogers, L.L. Smith, and R.D. Black report management positions and ownership interests in Scion NeuroStim. M. Kuchibhatla and M.D. Slade were contracted through Scion NeuroStim for statistical services. M.C. Freeman reports supports/grants/contracts from Alder, Allergan, Amgen, Dr. Reddy's Laboratories, Eli Lilly, Scion NeuroStim, and Teva. J.R. Saper reports supports/grants/contracts/consulting fees from Achelios, Alder, Allergan, Amgen, Asellas, Autonomic Technologies, Daiichi Sankyo, Dr. Reddy's Laboratories, Eli Lilly, Gavis, GlaxoSmithKline, Labrys Biologics, Merck, Migraine Research Foundation, Pfizer, Scion NeuroStim, Supurnus, Teva, Tian, Tonix, and Zecuity. M. Sakel reports speaker fee/honoraria from Allergan, Merz, IPSEN, Pfizer, REX Bionics, and Eisai. A.H. Calhoun reports support/honoraria/consulting fees from Allergan, Autonomic Technologies, Depomed, ElectroCore Medical, Merck, Scion NeuroStim, and Teva. Statistical analysis was performed by M. Kuchibhatla and M.D. Slade.
Abstract
Background
Migraine causes significant disability in ∼12% of the world population. No current migraine preventive treatment provides full clinical relief, and many exhibit high rates of discontinuation due to adverse events. Thus, new therapeutic options are needed. CVS may be an effective and safe adjuvant-therapy for the prevention of episodic migraine.
Methods
In a multicenter, parallel-arm, block-randomized, placebo-controlled clinical trial (clinicaltrials.gov: NCT01899040), subjects completed a 3-month treatment with the TNM™ device for CVS (refer to Fig. 2 for patient enrollment and allocation). The primary endpoint was the change in monthly migraine days from baseline to the third treatment month. Secondary endpoints were 50% responder rates, change in prescription analgesic usage and difference in total subjective headache-related pain scores. Device safety assessments included evaluation of any impact on mood, cognition, or balance.
Results
Per-protocol, active-arm subjects showed immediate and continued steady declines in migraine frequency over the treatment period. After 3 months of treatment, active-arm subjects exhibited significantly fewer migraine days (−3.9 ± 0.6 from a baseline burden of 7.7 ± 0.5 migraine days). These improvements were significantly greater than those observed in control subjects (−1.1 ± 0.6 from a baseline burden = 6.9 ± 0.7 migraine days) and represented a therapeutic gain of −2.8 migraine days, CI = −0.9 to −4.7, P = .012. Active arm subjects also reported greater reductions in acute medication usage and monthly pain scores compared to controls. No adverse effects on mood, cognition, or balance were reported. Subjects completed the trial with an average rate of 90% treatment adherence. No serious or unexpected adverse events were recorded. The rate of expected adverse events was similar across the active and the placebo groups, and evaluation confirmed that subject blinding remained intact.
Conclusion
The TNM™ device for CVS appears to provide a clinically efficacious and highly tolerable adjuvant therapy for the prevention of episodic migraine.