Jin Woo Chang1, Chang Kyu Park1, Nir Lipsman2, Michael L Schwartz2, Pejman Ghanouni3, Jaimie M Henderson4, Ryder Gwinn5, Jennifer Witt5, Travis S Tierney6, G Rees Cosgrove7, Binit B Shah8, Keiichi Abe9, Takaomi Taira9, Andres M Lozano10, Howard M Eisenberg11, Paul S Fishman12, W Jeffrey Elias13. 1. Department of Neurosurgery Yonsei University College of Medicine, Seoul, South Korea. 2. Department of Neurosurgery Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. 3. Department of Radiology, Stanford University School of Medicine, Stanford, CA. 4. Department of Neurosurgery, Stanford University School of Medicine, Stanford, CA. 5. Department of Neurosurgery Swedish Neuroscience Institute, Seattle, WA. 6. Department of Neurosurgery, University of Miami School of Medicine, Nicklaus Children's Hospital, Miami, FL. 7. Department of Neurosurgery, Brigham and Women's Hospital, Boston, MA. 8. Department of Neurology, University of Virginia Health Sciences Center, Charlottesville, VA. 9. Department of Neurosurgery, Tokyo Women's Medical University, Tokyo, Japan. 10. Department of Neurosurgery, University of Toronto, Toronto, Ontario, Canada. 11. Departments of Neurosurgery. 12. Neurology, University of Maryland, Baltimore, MD. 13. Department of Neurosurgery, University of Virginia Health Sciences Center, Charlottesville, VA.
Abstract
OBJECTIVE:Magnetic resonance guided focused ultrasound (MRgFUS) has recently been investigated as a new treatment modality for essential tremor (ET), but the durability of the procedure has not yet been evaluated. This study reports results at a 2- year follow-up after MRgFUS thalamotomy for ET. METHODS: A total of 76 patients with moderate-to-severe ET, who had not responded to at least two trials of medical therapy, were enrolled in the original randomized study of unilateral thalamotomy and evaluated using the clinical rating scale for tremor. Sixty-seven of the patients continued in the open-label extension phase of the study with monitoring for 2 years. Nine patients were excluded by 2 years, for example, because of alternative therapy such as deep brain stimulation (n = 3) or inadequate thermal lesioning (n = 1). However, all patients in each follow-up period were analyzed. RESULTS:Mean hand tremor score at baseline (19.8 ± 4.9; 76 patients) improved by 55% at 6 months (8.6 ± 4.5; 75 patients). The improvement in tremor score from baseline was durable at 1 year (53%; 8.9 ± 4.8; 70 patients) and at 2 years (56%; 8.8 ± 5.0; 67 patients). Similarly, the disability score at baseline (16.4 ± 4.5; 76 patients) improved by 64% at 6 months (5.4 ± 4.7; 75 patients). This improvement was also sustained at 1 year (5.4 ± 5.3; 70 patients) and at 2 years (6.5 ± 5.0; 67 patients). Paresthesias and gait disturbances were the most common adverse effects at 1 year-each observed in 10 patients with an additional 5 patients experiencing neurological adverse effects. None of the adverse events worsened over the period of follow-up, and 2 of these resolved. There were no new delayed complications at 2 years. INTERPRETATION: Tremor suppression after MRgFUS thalamotomy for ET is stably maintained at 2 years. Latent or delayed complications do not develop after treatment. Ann Neurol 2018;83:107-114.
RCT Entities:
OBJECTIVE: Magnetic resonance guided focused ultrasound (MRgFUS) has recently been investigated as a new treatment modality for essential tremor (ET), but the durability of the procedure has not yet been evaluated. This study reports results at a 2- year follow-up after MRgFUS thalamotomy for ET. METHODS: A total of 76 patients with moderate-to-severe ET, who had not responded to at least two trials of medical therapy, were enrolled in the original randomized study of unilateral thalamotomy and evaluated using the clinical rating scale for tremor. Sixty-seven of the patients continued in the open-label extension phase of the study with monitoring for 2 years. Nine patients were excluded by 2 years, for example, because of alternative therapy such as deep brain stimulation (n = 3) or inadequate thermal lesioning (n = 1). However, all patients in each follow-up period were analyzed. RESULTS: Mean hand tremor score at baseline (19.8 ± 4.9; 76 patients) improved by 55% at 6 months (8.6 ± 4.5; 75 patients). The improvement in tremor score from baseline was durable at 1 year (53%; 8.9 ± 4.8; 70 patients) and at 2 years (56%; 8.8 ± 5.0; 67 patients). Similarly, the disability score at baseline (16.4 ± 4.5; 76 patients) improved by 64% at 6 months (5.4 ± 4.7; 75 patients). This improvement was also sustained at 1 year (5.4 ± 5.3; 70 patients) and at 2 years (6.5 ± 5.0; 67 patients). Paresthesias and gait disturbances were the most common adverse effects at 1 year-each observed in 10 patients with an additional 5 patients experiencing neurological adverse effects. None of the adverse events worsened over the period of follow-up, and 2 of these resolved. There were no new delayed complications at 2 years. INTERPRETATION:Tremor suppression after MRgFUS thalamotomy for ET is stably maintained at 2 years. Latent or delayed complications do not develop after treatment. Ann Neurol 2018;83:107-114.
Authors: William K Miller; Kathryn N Becker; Andrew J Caras; Tarek R Mansour; Malik T Mays; Mehmood Rashid; Jason Schwalb Journal: Neurosurg Rev Date: 2021-05-12 Impact factor: 3.042