Clinical trial NCT04991831: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tremor Associated With Tremor Dominant Parkinson's Disease
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility 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.

Primary outcomes:
measure: Long-term adverse events.
timeFrame: Five years.
Secondary outcomes:
measure: Tremor/motor intensity and impact on disability
timeFrame: Five years.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Neuroscience Institute Baptist Health
state: Florida
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Huntsville
country: United States
facility: Novant Health Brain & Spine Surgery
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Fairborn
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Dundee
country: United Kingdom
facility: University of Dundee
state: Scotland
Study officials:
References: