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A pilot trial of square biphasic pulse deep brain stimulation for dystonia: The BIP dystonia study
Leonardo Almeida1, Daniel Martinez-Ramirez1, Bilal Ahmed1
1Department of Neurology, Center for Movement Disorders and Neurorestoration, University of Florida, Department of Neurology, Gainesville, Florida, USA.
Background:
Dystonia often has inconsistent benefits and requires more energy-demanding DBS settings. Studies suggest that squared biphasic pulses could provide significant clinical benefit; however, dystonia patients have not been explored.
Objectives:
To assess safety and tolerability of square biphasic DBS in dystonia patients.
Methods:
This study included primary generalized or cervical dystonia patients with bilateral GPi DBS. Square biphasic pulses were implemented and patients were assessed at baseline, immediately postwashout, post-30-minute washout, 1 hour post- and 2 hours postinitiation of investigational settings.
Results:
Ten participants completed the study. There were no patient-reported or clinician-observed side effects. There was improvement across time on the Toronto Western Spasmodic Torticollis Rating Scale (χ2 = 10.7; P = 0.031). Similar improvement was detected in objective gait measurements.
Conclusions:
Square biphasic stimulation appears safe and feasible in dystonia patients with GPi DBS. Further studies are needed to evaluate possible effectiveness particularly in cervical and gait features. © 2016 International Parkinson and Movement Disorder Society.
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