PMID- 33481557
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230619
IS  - 1933-0693 (Electronic)
IS  - 0022-3085 (Linking)
VI  - 135
IP  - 3
DP  - 2020 Nov 27
TI  - MR-guided focused ultrasound pallidotomy for Parkinson's disease: safety and 
      feasibility.
PG  - 792-798
LID - 10.3171/2020.6.JNS192773 [doi]
AB  - OBJECTIVE: Stereotactic radiofrequency pallidotomy has demonstrated improvement 
      in motor fluctuations in patients with Parkinson's disease (PD), particularly 
      levodopa (L-dopa)-induced dyskinesias. The authors aimed to determine whether or 
      not unilateral pallidotomy with MR-guided focused ultrasound (MRgFUS) could 
      safely improve Unified Dyskinesia Rating Scale (UDysRS; the primary outcome 
      measure) scores over baseline scores in patients with PD. METHODS: Twenty 
      patients with PD and L-dopa responsiveness, asymmetrical motor signs, and motor 
      fluctuations, including dyskinesias, participated in a 1-year multicenter 
      open-label trial of unilateral MRgFUS ablation of the globus pallidus internus. 
      RESULTS: The sonication procedure was successfully completed in all 20 enrolled 
      patients. MRgFUS-related adverse neurological events were generally mild and 
      transient, including visual field deficit (n = 1), dysarthria (n = 4, 2 mild and 
      2 moderate), cognitive disturbance (n = 1), fine motor deficit (n = 2), and 
      facial weakness (n = 1). Although 3 adverse events (AEs) were rated as severe 
      (transient sonication-related pain in 2, nausea/vomiting in 1), no AE fulfilled 
      US FDA criteria for a Serious Adverse Effect. Total UDysRS, the primary outcome 
      measure, improved 59% after treatment (baseline mean score 36.1, 95% CI 4.88; at 
      3 months 14.2, 95% CI 5.72, p < 0.0001), which was sustained throughout the study 
      (at 12 months 20.5, 95% CI 7.39, 43% improvement, p < 0.0001). The severity of 
      motor signs on the treated side (Movement Disorder Society version of the United 
      Parkinson's Disease Rating Scale [MDS-UPDRS] part III) in the "off" medication 
      state also significantly improved (baseline mean score 20.0, 95% CI 2.4; at 3 
      months 10.6, 95% CI 1.86, 44.5% improvement, p < 0.0001; at 12 months 10.4, 95% 
      CI 2.11, 45.2% improvement, p > 0.0001). The vast majority of patients showed a 
      clinically meaningful level of improvement on the impairment component of the 
      UDysRS or the motor component of the UPDRS, while 1 patient showed clinically 
      meaningful worsening on the UPDRS at month 3. CONCLUSIONS: This study supports 
      the feasibility and preliminary efficacy of MRgFUS pallidotomy in the treatment 
      of patients with PD and motor fluctuations, including dyskinesias. These 
      preliminary data support continued investigation, and a placebo-controlled, 
      blinded trial is in progress. Clinical trial registration no.: NCT02263885 
      (clinicaltrials.gov).
FAU - Eisenberg, Howard M
AU  - Eisenberg HM
AD  - Departments of1Neurosurgery.
FAU - Krishna, Vibhor
AU  - Krishna V
AD  - 2Department of Neurosurgery, Ohio State University Medical Center, Columbus, 
      Ohio.
FAU - Elias, W Jeffrey
AU  - Elias WJ
AD  - 3Department of Neurosurgery, University of Virginia Health Sciences Center, 
      Charlottesville, Virginia; and.
FAU - Cosgrove, G Rees
AU  - Cosgrove GR
AD  - 4Department of Neurosurgery, Brigham and Women's Hospital, Boston, Massachusetts.
FAU - Gandhi, Dheeraj
AU  - Gandhi D
AD  - 5Diagnostic Radiology and Nuclear Medicine, and.
FAU - Aldrich, Charlene E
AU  - Aldrich CE
AD  - Departments of1Neurosurgery.
FAU - Fishman, Paul S
AU  - Fishman PS
AD  - 6Neurology, University of Maryland School of Medicine, Baltimore, Maryland.
LA  - eng
SI  - ClinicalTrials.gov/NCT02263885
PT  - Journal Article
DEP - 20201127
PL  - United States
TA  - J Neurosurg
JT  - Journal of neurosurgery
JID - 0253357
SB  - IM
OTO - NOTNLM
OT  - MR-guided focused ultrasound
OT  - MRgFUS
OT  - Parkinson's disease
OT  - dyskinesia
OT  - functional neurosurgery
OT  - pallidotomy
EDAT- 2021/01/23 06:00
MHDA- 2021/01/23 06:01
CRDT- 2021/01/22 14:23
PHST- 2019/10/11 00:00 [received]
PHST- 2020/06/29 00:00 [accepted]
PHST- 2021/01/23 06:01 [medline]
PHST- 2021/01/23 06:00 [pubmed]
PHST- 2021/01/22 14:23 [entrez]
AID - 2020.6.JNS192773 [pii]
AID - 10.3171/2020.6.JNS192773 [doi]
PST - epublish
SO  - J Neurosurg. 2020 Nov 27;135(3):792-798. doi: 10.3171/2020.6.JNS192773.