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

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.

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 18 - 80 Status: Recruiting
Time Since Diagnosis: Less than 60 years Study Focus: Dyskinesia

Study Purpose:

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.

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More Details

Phase: N/A Lead Sponsor: InSightec
Trial ID: 004040 Sponsor Type: Industry
Primary Country: Canada Additional Collaborators or Sponsors:
Estimated Enrollment: 6 Study Start Date: September 2014
Estimated Study Completion Date: December 2018 Source: ClinicalTrials.gov
Study Website:

More Inclusion & Exclusion Criteria

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