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ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease
Sponsor: InSightec
Summary
The proposed study is to evaluate the safety and initial effectiveness of the ExAblate Transcranial MRgFUS) treatment of patients with L-dopa induced dyskinesia of Parkinson's disease (LID PD). Safety: To evaluate the incidence and severity of adverse events associated with ExAblate Transcranial 4000 MRgFUS treatment of dyskinesia of Parkinson's disease. Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial MRgFUS treatment of LID in PD patients. Efficacy will be determined utilizing clinical rating scales for dyskinesia (UPDRS-IV and the Unified Dyskinesia Rating Scale) from examinations at Baseline, 3-Months and 12-Months post-ExAblate treatment.
Official title: Feasibility Trial Evaluating the Safety and Efficacy of ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for Unilateral Pallidotomy for the Treatment of L-Dopa Induced Dyskinesia (LID) of Parkinson's Disease.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2014-09
Completion Date
2026-12
Last Updated
2025-05-01
Healthy Volunteers
No
Conditions
Interventions
Transcranial ExAblate
Transcranial ExAblate MRgFUS
Locations (1)
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada