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NCT04991831 | RECRUITING | Tremor Associated With Tremor Dominant Parkinson's Disease

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
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.

Condition or disease

Tremor Associated With Tremor Dominant Parkinson's Disease

Intervention/treatment

Unilateral thalamotomy

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
Estimated Enrollment : 50 participants
Official Title : 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
Actual Study Start Date : 2022-04-28
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
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

Location Details

NCT04991831

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Miami Neuroscience Institute Baptist Health

Miami, florida, United States, 33176

RECRUITING

United States, Illinois

Rush University

Chicago, Illinois, United States, 60612

RECRUITING

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, New York

Weill Cornell Medicine

New York, New York, United States, 10065

RECRUITING

United States, North Carolina

Novant Health Brain & Spine Surgery

Huntsville, North Carolina, United States, 28708

RECRUITING

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Ohio

Miami Valley Hospital

Fairborn, Ohio, United States, 45324

RECRUITING

United Kingdom, Scotland

University of Dundee

Dundee, Scotland, United Kingdom, DD1 9SY