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

March 18, 2026 updated by: InSightec
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Scotland
  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Neuroscience Institute Baptist Health
        • Principal Investigator:
          • Justin Sporrer, MD
        • Contact:
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University
        • Principal Investigator:
          • Neepa Patel, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Kaplitt, MD, PhD
    • North Carolina
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Sean Nagel, MD
        • Contact:
      • Fairborn, Ohio, United States, 45324

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patient population enrolled in this registry will be comprised of male and female patients that plan to be treated for TDPD using the Exablate Neuro system.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post Exablate Neuro Thalamotomy for Tremor Associated with Tremor Dominant Parkinson's Disease
This is a post Exablate Neuro Thalamotomy registry. No intervention is performed under this registry protocol.
Device: Unilateral thalamotomy
Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term adverse events.
Time Frame: Five years.
This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system.
Five years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tremor/motor intensity and impact on disability
Time Frame: 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)
Five years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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