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Trial of Globus Pallidus Focused Ultrasound Ablation in Parkinson's Diseas

Authors
 Vibhor Krishna  ;  Paul S Fishman  ;  Howard M Eisenberg  ;  Michael Kaplitt  ;  Gordon Baltuch  ;  Jin Woo Chang  ;  Wei-Chieh Chang  ;  Raul Martinez Fernandez  ;  Marta Del Alamo  ;  Casey H Halpern  ;  Pejman Ghanouni  ;  Roberto Eleopra  ;  Rees Cosgrove  ;  Jorge Guridi  ;  Ryder Gwinn  ;  Pravin Khemani  ;  Andres M Lozano  ;  Nathan McDannold  ;  Alfonso Fasano  ;  Marius Constantinescu  ;  Ilana Schlesinger  ;  Arif Dalvi  ;  W Jeff Elias 
Citation
 NEW ENGLAND JOURNAL OF MEDICINE, Vol.388(8) : 683-693, 2023-02 
Journal Title
NEW ENGLAND JOURNAL OF MEDICINE
ISSN
 0028-4793 
Issue Date
2023-02
MeSH
Dyskinesias / etiology ; Dyskinesias / surgery ; Globus Pallidus* / surgery ; High-Intensity Focused Ultrasound Ablation* ; Humans ; Parkinson Disease* / complications ; Parkinson Disease* / surgery ; Treatment Outcome
Abstract
BACKGROUND: Unilateral focused ultrasound ablation of the internal segment of globus pallidus has reduced motor symptoms of Parkinson's disease in open-label studies.

METHODS: We randomly assigned, in a 3:1 ratio, patients with Parkinson's disease and dyskinesias or motor fluctuations and motor impairment in the off-medication state to undergo either focused ultrasound ablation opposite the most symptomatic side of the body or a sham procedure. The primary outcome was a response at 3 months, defined as a decrease of at least 3 points from baseline either in the score on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale, part III (MDS-UPDRS III), for the treated side in the off-medication state or in the score on the Unified Dyskinesia Rating Scale (UDysRS) in the on-medication state. Secondary outcomes included changes from baseline to month 3 in the scores on various parts of the MDS-UPDRS. After the 3-month blinded phase, an open-label phase lasted until 12 months.

RESULTS: Of 94 patients, 69 were assigned to undergo ultrasound ablation (active treatment) and 25 to undergo the sham procedure (control); 65 patients and 22 patients, respectively, completed the primary-outcome assessment. In the active-treatment group, 45 patients (69%) had a response, as compared with 7 (32%) in the control group (difference, 37 percentage points; 95% confidence interval, 15 to 60; P = 0.003). Of the patients in the active-treatment group who had a response, 19 met the MDS-UPDRS III criterion only, 8 met the UDysRS criterion only, and 18 met both criteria. Results for secondary outcomes were generally in the same direction as those for the primary outcome. Of the 39 patients in the active-treatment group who had had a response at 3 months and who were assessed at 12 months, 30 continued to have a response. Pallidotomy-related adverse events in the active-treatment group included dysarthria, gait disturbance, loss of taste, visual disturbance, and facial weakness.

CONCLUSIONS: Unilateral pallidal ultrasound ablation resulted in a higher percentage of patients who had improved motor function or reduced dyskinesia than a sham procedure over a period of 3 months but was associated with adverse events. Longer and larger trials are required to determine the effect and safety of this technique in persons with Parkinson's disease. (Funded by Insightec; ClinicalTrials.gov number, NCT03319485.). Copyright © 2023 Massachusetts Medical Society.
Full Text
https://www.nejm.org/doi/10.1056/NEJMoa2202721
DOI
10.1056/NEJMoa2202721
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Neurosurgery (신경외과학교실) > 1. Journal Papers
Yonsei Authors
Chang, Jin Woo(장진우) ORCID logo https://orcid.org/0000-0002-2717-0101
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/195367
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