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ACTIVE NOT RECRUITING
NCT02347254
NA

ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease

Sponsor: InSightec

View on ClinicalTrials.gov

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

Interventions

DEVICE

Transcranial ExAblate

Transcranial ExAblate MRgFUS

Locations (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada