학술논문

Double blind, nonrandomized crossover study of active recharge biphasic deep brain stimulation for primary dystonia
Document Type
article
Source
Subject
Biomedical and Clinical Sciences
Clinical Sciences
Brain Disorders
Rare Diseases
Neurodegenerative
Assistive Technology
Bioengineering
Neurosciences
Clinical Trials and Supportive Activities
Dystonia
Clinical Research
Rehabilitation
Humans
Cross-Over Studies
Deep Brain Stimulation
Dystonic Disorders
Globus Pallidus
Pilot Projects
Treatment Outcome
Deep brain stimulation
Active recharge
Globus pallidus
Cognitive Sciences
Neurology & Neurosurgery
Clinical sciences
Biological psychology
Language
Abstract
BackgroundDeep brain stimulation (DBS) of the globus pallidus interna (GPi) is an effective therapy for select patients with primary dystonia. DBS programming for dystonia is often challenging due to variable time to symptomatic improvement or stimulation induced side effects (SISE) such as capsular or optic tract activation which can prolong device optimization.ObjectiveTo characterize the safety and tolerability of active recharge biphasic DBS (bDBS) in primary dystonia and to compare it to conventional clinical DBS (clinDBS).MethodsTen subjects with primary dystonia and GPi DBS underwent a single center, double blind, nonrandomized crossover study comparing clinDBS versus bDBS. The testing occurred over two-days. bDBS and clinDBS were administered on separate days and each was activated for 6 h. Rating scales were collected by video recording and scored by four blinded movement disorders trained neurologists.ResultsThe bDBS paradigm was safe and well-tolerated in all ten subjects. There were no persistent SISE reported. The mean change in the Unified Dystonia Rating Scale after 4 h of stimulation was greater in bDBS when compared to clinDBS (-6.5 vs 0.3, p