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

Description

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.

Conditions

Tremor Associated With Tremor Dominant Parkinson's Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Tremor Associated With Tremor Dominant Parkinson's Disease
Intervention / Treatment

-

Contacts and Locations

Chicago

Rush University, Chicago, Illinois, United States, 60612

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

30 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

InSightec,

Study Record Dates

2027-12