Research Submissions

Preventing Episodic Migraine With Caloric Vestibular Stimulation: A Randomized Controlled Trial

David Wilkinson PhD

David Wilkinson PhD

School of Psychology, University of Kent, Canterbury, Kent, UK

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Kristen K. Ade PhD

Corresponding Author

Kristen K. Ade PhD

Scion NeuroStim, LLC, Raleigh, NC

Address all correspondence to Kristen Ade, PhD, Scion NeuroStim, LLC, 3105 Cone Manor Lane, Raleigh, NC 26713-6606, USA, email: [email protected]Search for more papers by this author
Lesco L. Rogers MD

Lesco L. Rogers MD

Scion NeuroStim, LLC, Raleigh, NC

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Deborah K. Attix PhD

Deborah K. Attix PhD

Department of Neurology, Duke University Medical Center, Durham, NC

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Maragatha Kuchibhatla PhD

Maragatha Kuchibhatla PhD

Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC

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Martin D. Slade MPH

Martin D. Slade MPH

School of Public Health, Yale University, New Haven, CT

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Lanty L. Smith LLB

Lanty L. Smith LLB

Scion NeuroStim, LLC, Raleigh, NC

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Kathryn P. Poynter RN

Kathryn P. Poynter RN

Scion NeuroStim, LLC, Raleigh, NC

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Daniel T. Laskowitz MD

Daniel T. Laskowitz MD

Department of Neurology, Duke University Medical Center, Durham, NC

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Marshall C. Freeman MD

Marshall C. Freeman MD

Headache Wellness Center, Greensboro, NC

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Michael E. Hoffer MD

Michael E. Hoffer MD

Department of Otolaryngology, University of Miami Miller School of Medicine, Miami, FL

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Joel R. Saper MD

Joel R. Saper MD

Michigan Headache and Neurological Institute, Ann Arbor, MI

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Dianne L. Scott MD

Dianne L. Scott MD

Department of Anesthesiology, Duke University Medical Center, Durham, NC, USA

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Mohamed Sakel MD

Mohamed Sakel MD

East Kent Neuro-Rehabilitation Service, East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, UK

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Anne H. Calhoun MD

Anne H. Calhoun MD

Carolina Headache Institute, Chapel Hill, NC, USA

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Robert D. Black PhD

Robert D. Black PhD

Scion NeuroStim, LLC, Raleigh, NC

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First published: 27 June 2017
Citations: 41

Study Funding: This study was funded by Scion NeuroStim, LLC, USA.

Study Registration: clinicaltrials.gov: NCT01899040.

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

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.

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, = .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.