A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

NCT04991831 · tracked via the Priya Life Science USA tracker

Sponsor

InSightec

Phase

Observational

Started

2022-04-28

Last updated

2026-03-20

Condition(s) studied

Tremor Associated With Tremor Dominant Parkinson's Disease

Investigational drug(s) / intervention(s)

Unilateral thalamotomy

Unilateral thalamotomy: Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.

Study summary

The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.

Eligibility

Sex

ALL

Min age

30 Years

Max age

99 Years

Healthy volunteers

Inclusion Criteria: 1. Men and women, age 30 years and older 2. Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care. 3. Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits 4. 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 study.

Primary outcome measure(s)

Long-term adverse events. — Five years.
This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system.

Trial sites (8)

Facility	City	Region	Status
Miami Neuroscience Institute Baptist Health	Miami	Florida	Recruiting
Rush University	Chicago	Illinois	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
Weill Cornell Medicine	New York	New York	Recruiting
Novant Health Brain & Spine Surgery	Huntsville	North Carolina	Recruiting
Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
Miami Valley Hospital	Fairborn	Ohio	Recruiting
University of Dundee	Dundee	Scotland	Recruiting

More InSightec trials in the USA

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

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 Recruiting

Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG) Active, not recruiting

ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease Recruiting

A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects 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 NCT04991831 on ClinicalTrials.gov ↗ ← All trials in the USA