Actively Recruiting
Post-Approval Registry for Exablate 4000 Type 1.0 and 1.1 Unilateral Pallidotomy for Advanced Idiopathic Parkinson's Disease with Medication-Refractory Motor Complications
Led by InSightec · Updated on 2026-03-20
60
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are monitoring people with advanced idiopathic Parkinson's Disease who have moderate to severe motor symptoms that do not respond well to medication. This study is an international, observational registry following patients who have undergone a unilateral pallidotomy using the Exablate Neuro device. The goal is to collect long-term information about this treatment after its approval. The treatment involves a focused ultrasound procedure called unilateral pallidotomy performed with the Exablate Model 4000 system. This registry will observe patients who have already received this procedure as part of their standard care. No additional treatment is given as part of the study. Patients will be followed with visits at 3, 6, and 12 months after the procedure, and then annually for up to 5 years. During the follow-up visits, researchers will collect information including any side effects, medication use, motor function scores, dyskinesia severity, quality of life, work productivity, and overall impressions from both doctors and patients. Safety and effectiveness will be assessed mainly by tracking responder outcomes over five years. Participants will be closely monitored throughout the study period, which may last up to five years from the time of the procedure.
CONDITIONS
Brief Title
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 30 years and older
- Planning to undergo a unilateral pallidotomy using the Exablate Neuro system for Parkinson's Disease with motor complications
- Willing to comply with the registry requirements and complete all visits
- Signed and received a copy of the informed consent form
You will not qualify if you...
- Does not agree to participate or is unlikely to participate for the entire duration of the registry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants who have undergone unilateral pallidotomy using the Exablate Neuro system are observed with assessments including adverse events, medication usage, motor function scales, quality of life, and satisfaction questionnaires.
Visits at baseline, 3, 6, and 12 months post-procedure and annually thereafter for 5 years
Trial Site Locations
Total: 5 locations
1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
4
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
5
Ohnishi Neurological Center
Akashi, Hyōgo, Japan, 674-0064
Actively Recruiting
Research Team
K
Kingsley Nwaogu
J
Julia Zhu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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