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
Recruiting · NCT04991831 · Observational (researchers observe without assigning treatment) · Lead sponsor: InSightec
View the official record on ClinicalTrials.gov →Interventions studied
Unilateral thalamotomy
What this trial is about
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.
Who can take part
Age range
30 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Men and women, age 30 years and older
- Subject undergoing an Exablate procedure for their planned TDPD treatment; per local institution standard of care.
- Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all study visits
- 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.
Where it is running
8 locations listed across 6 US states.
- Miami Neuroscience Institute Baptist Health - Miami, Florida, United States
- Rush University - Chicago, Illinois, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Weill Cornell Medicine - New York, New York, United States
- Novant Health Brain & Spine Surgery - Huntsville, North Carolina, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- Miami Valley Hospital - Fairborn, Ohio, United States
- University of Dundee - Dundee, Scotland, United Kingdom