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

Recruiting

• Conditions: Tremor Associated With Tremor Dominant Parkinson's Disease
• Interventions: Device: Unilateral thalamotomy

• Registration Number: NCT04991831
• Lead Sponsor: InSightec

Brief 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.

Detailed Description

This is a post-approval registry which is required by of the approval under PMA P150038/S006 for the Exablate® Model 4000 (Exablate Neuro) Type 1.0 and Type 1.1 for unilateral thalamotomy in the treatment of medication refractory Tremor Dominant Parkinson's Disease (TDPD). Subjects participating in this registry will have received a unilateral thalamotomy (ventralis medius) prior to enrollment using the commercially available Exablate Neuro for the treatment of Essential tremor and TDPD.

The following assessments will be collected at Baseline,1, 3, 6, and 12 months post Exablate procedure and annually thereafter for 5 years:

* Adverse Events (AEs) (does not apply to Baseline Visit)

* Medication usage

* Clinical Rating Scale for Tremor (CRST) ON medication

* Unified Parkinson's Disease Rating Scale Part III ON medication

* EQ-5D-5L

* WPAI-GH

Study Timeline

• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-08-05
• Study Start: 2022-04-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease	Unilateral thalamotomy	This is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Tremor/motor intensity and impact on disability	Five years.	Long term tremor motor scores and the impact of tremor on disability will be monitored using components of the Clinical Rating Scale for Tremor (CRST)

Trial Locations

Locations (8)

Miami Neuroscience Institute Baptist Health; 🇺🇸 Miami, Florida, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Novant Health Brain & Spine Surgery; 🇺🇸 Huntsville, North Carolina, United States

Miami Valley Hospital; 🇺🇸 Fairborn, Ohio, United States

University of Dundee; 🇬🇧 Dundee, Scotland, United Kingdom

Rush University; 🇺🇸 Chicago, Illinois, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States