ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease
NCT02347254 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2025-05-01
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.
Conditions
Interventions
- DEVICE
-
Transcranial ExAblate
Transcranial ExAblate MRgFUS
Sponsors & Collaborators
-
InSightec
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2026-06-30
- Completion
- 2026-12-31
Countries
- Canada
Study Locations
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