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Purpose

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

Eligibility

Eligible Ages
Between 30 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
John Rolston, MD, PhD
jrolston@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
InSightec

Study Contact

Mark Grassman, Ph.D.
214-630-2000
markg@insightec.com

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.