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Clinical Trials in the USA / NCT05539196
Recruiting Observational

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

NCT05539196 · tracked via the Priya Life Science USA tracker
Sponsor
InSightec
Phase
Observational
Started
2023-01-23
Last updated
2026-03-20

Condition(s) studied

Movement DisordersNeurologyParkinsons Disease

Investigational drug(s) / intervention(s)

Exablate Pallidotomy, Unilateral

Exablate Pallidotomy, Unilateral: Unilateral pallidotomy using focused ultrasound for the treatment of Parkinson's Disease with medication-refractory moderate to severe motor complications.

Study summary

This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.

Eligibility

Sex
ALL
Min age
30 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Men and women, age 30 years and older. * Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care. * Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry visits. * Subject has signed and received a copy of the approved informed consent form. Exclusion Criteria: * Subject does not agree to participate or is unlikely to participate for the entirety of the Registry.

Primary outcome measure(s)

  • Responder Analysis — 5 years
    Primary Effectiveness will be evaluated through a Responder analysis. Responder is defined as the patient reaching a minimally clinically significant difference on: 1) UDysRS Objective Assessment ON Meds, without clinically significant worsening of MDS-UPDRS Part III OFF Meds aggregated extremity score for treated side Or 2) MDS-UPDRS Part III OFF Meds Motor Exam on the treated side, without clinically significant worsening of UDysRS Objective Assessment ON meds

Trial sites (5)

FacilityCityRegionStatus
University of Maryland, Baltimore Baltimore Maryland Recruiting
Weill Cornell Medicine New York New York Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Ohnishi Neurological Center Akashi Hyōgo Recruiting

More InSightec trials in the USA

Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG) Active, not recruiting
Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD) Active, not recruiting
Bilateral Treatment of Medication Refractory Essential Tremor Active, not recruiting
ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease Recruiting
Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids Recruiting

Other trials for the same condition

Abbott DBS Post-Market Study of Outcomes for Indications Over Time Recruiting
Analysis of Human Movement With Assistive Devices Recruiting
A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease Active, not recruiting
Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders: Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05539196 on ClinicalTrials.gov ↗ ← All trials in the USA