Kyle T Mitchell1, Paul Larson2, Philip A Starr3, Michael S Okun4, Robert E Wharen5, Ryan J Uitti6, Barton L Guthrie7, DeLea Peichel8, Rajesh Pahwa9, Harrison C Walker10, Kelly Foote11, Frederick J Marshall12, Joseph Jankovic13, Richard Simpson14, Fenna Phibbs15, Joseph S Neimat16, R Malcolm Stewart17, Khashayar Dashtipour18, Jill L Ostrem19. 1. Department of Neurology, University of California San Francisco and the San Francisco Veteran's Affairs Medical Center, 1635 Divisadero Street, 5th Floor, Suite 520, San Francisco, CA 94115, USA. Electronic address: kyle.mitchell@duke.edu. 2. Department of Neurological Surgery, University of California San Francisco and the San Francisco Veteran's Affairs Medical Center, 1635 Divisadero Street, 5th Floor, Suite 520-530, San Francisco, CA, 94115, USA. Electronic address: paul.larson@ucsf.edu. 3. Department of Neurological Surgery, University of California San Francisco and the San Francisco Veteran's Affairs Medical Center, 1635 Divisadero Street, 5th Floor, Suite 520-530, San Francisco, CA, 94115, USA. Electronic address: philip.starr@ucsf.edu. 4. Departments of Neurology and Neurosurgery, University of Florida Fixel Center for Neurological Diseases and the Movement Disorders and Neurorestoration Program, 3450 Hull Road, 4th Floor, Gainesville, FL, 32607, USA. Electronic address: okun@neurology.ufl.edu. 5. Department of Neurosurgery, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL, 32224, USA. Electronic address: wharen.robert@mayo.edu. 6. Department of Neurology, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL 32224, USA. Electronic address: Uitti.ryan@mayo.edu. 7. Department of Neurosurgery, University of Alabama Birmingham, School of Medicine, 510 20th Avenue South, FOT 1038, Birmingham, AL, 35234, USA. Electronic address: bguthrie@uabmc.edu. 8. Abbott, Clinical Research Department, 6901 Preston Road, Plano, TX, 75024, USA. Electronic address: deleapeichel@yahoo.com. 9. Department of Neurology, University of Kansas Medical Center, Parkinson's Disease and Movement Disorder Center, 3599 Rainbow Blvd, Mailstop 2012, Kansas City, KS, 66160, USA. Electronic address: RPAHWA@kumc.edu. 10. Department of Neurology, University of Alabama Birmingham, School of Medicine, 510 20th Avenue South, FOT 1038 Birmingham, AL 35234, USA. Electronic address: hcwalker@uabmc.edu. 11. Department of Neurosurgery, University of Florida Fixel Center for Neurological Diseases and the Movement Disorders and Neurorestoration Program, 3450 Hull Road, 4th Floor, Gainesville, FL 32607, USA. Electronic address: foote@neurosurgery.ufl.edu. 12. Department of Neurology, University of Rochester, 919 Westfall Rd., Bldg C, Suite 220, Rochester, NY, 14618, USA. Electronic address: Frederick_marshall@urmc.rochester.edu. 13. Department of Neurology, Baylor College of Medicine, Parkinson's Disease Center and Movement Disorders Clinic, 7200 Cambridge, Suite 9A, Houston, TX, 77030, USA. Electronic address: josephj@bcm.edu. 14. Department of Neurosurgery, The Methodist Hospital Physician Organization, 6560 Fannin, Suite 944, Houston, TX, 77030, USA. Electronic address: RSimpson@houstonmethodist.org. 15. Department of Neurology, Vanderbilt University, A-0118 Medical Center North, Nashville, TN, 37232-2551, USA. Electronic address: fenna.phibbs@Vanderbilt.edu. 16. Department of Neurosurgery, Louisville Neuroscience, USA. Electronic address: joseph.neimat@louisvilleneuroscience.com. 17. Department of Neurology, Institute of Bioinformatics and Computational Biology, Tandy School of Computer Science, The University of Tulsa, 800 South Tucker Drive, Tulsa, OK, 74194-9700, USA. Electronic address: stewart4765@sbcglobal.net. 18. Department of Neurology, Loma Linda University Health System, 11370 Anderson St, Suite B-100, Loma Linda, CA, 92354, USA. Electronic address: KDashtipour@llu.edu. 19. Department of Neurology, University of California San Francisco, 1635 Divisadero Street, 5th Floor, Suite 520-530, San Francisco, CA 94115, USA. Electronic address: jill.ostrem@ucsf.edu.
Abstract
INTRODUCTION: Many experts assume bilateral deep brain stimulation (DBS) is necessary to improve axial tremor in essential tremor (ET). In the largest clinical trial of DBS for ET to date evaluating a non-directional, constant current device, we studied the effects of unilateral and staged bilateral DBS on axial tremor. METHODS: We included all participants from the original trial with unilateral ventral intermediate nucleus (VIM) DBS and 90-day follow up at minimum. Primary outcomes were changes in pooled axial subscores in the Clinical Rating Scale for Tremor (CRST) at 90 and 180 days after activation of unilateral VIM DBS compared to pre-operative baseline (n=119). Additionally, we performed within-subject analyses for unilateral versus bilateral DBS at 180 days in the cohort who underwent staged surgery to bilateral DBS (n=39). RESULTS: Unilateral VIM DBS improved midline tremor by 58% at 90 days (median[IQR]) (3[3] to 1[2], p<0.001) and 65% at 180 days (3[3] to 1[2], p<0.001) versus pre-op baseline. In the staged to bilateral DBS cohort, midline tremor scores further improved after bilateral DBS at 180 days by 63% versus unilateral DBS (3[3] to 1[3], p=0.007). There were, however, 35 additional DBS and surgery-related adverse events, 14 related to incoordination, gait impairment, or speech impairment, versus 6 after unilateral DBS. CONCLUSION: Unilateral VIM DBS for ET significantly improved associated axial tremor. Staged bilateral DBS was associated with additional axial tremor improvement but also additional adverse events. Unilateral VIM DBS may be sufficient to achieve a goal of contralateral limb and axial tremor attenuation.
INTRODUCTION: Many experts assume bilateral deep brain stimulation (DBS) is necessary to improve axial tremor in essential tremor (ET). In the largest clinical trial of DBS for ET to date evaluating a non-directional, constant current device, we studied the effects of unilateral and staged bilateral DBS on axial tremor. METHODS: We included all participants from the original trial with unilateral ventral intermediate nucleus (VIM) DBS and 90-day follow up at minimum. Primary outcomes were changes in pooled axial subscores in the Clinical Rating Scale for Tremor (CRST) at 90 and 180 days after activation of unilateral VIM DBS compared to pre-operative baseline (n=119). Additionally, we performed within-subject analyses for unilateral versus bilateral DBS at 180 days in the cohort who underwent staged surgery to bilateral DBS (n=39). RESULTS: Unilateral VIM DBS improved midline tremor by 58% at 90 days (median[IQR]) (3[3] to 1[2], p<0.001) and 65% at 180 days (3[3] to 1[2], p<0.001) versus pre-op baseline. In the staged to bilateral DBS cohort, midline tremor scores further improved after bilateral DBS at 180 days by 63% versus unilateral DBS (3[3] to 1[3], p=0.007). There were, however, 35 additional DBS and surgery-related adverse events, 14 related to incoordination, gait impairment, or speech impairment, versus 6 after unilateral DBS. CONCLUSION: Unilateral VIM DBS for ET significantly improved associated axial tremor. Staged bilateral DBS was associated with additional axial tremor improvement but also additional adverse events. Unilateral VIM DBS may be sufficient to achieve a goal of contralateral limb and axial tremor attenuation.
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