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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
RECRUITINGSponsored by InSightec
Actively Recruiting
SponsorInSightec
Started2022-04-28
Est. completion2027-12
Eligibility
Age30 Years – 99 Years
Healthy vol.Accepted
Locations7 sites
View on ClinicalTrials.gov →
NCT04991831
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.
Eligibility
Age: 30 Years – 99 YearsHealthy volunteers accepted
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.
Conditions2
Parkinson's DiseaseTremor Associated With Tremor Dominant Parkinson's Disease
Locations7 sites
Miami Neuroscience Institute Baptist Health
Miami, Florida, 33176
Brigham and Women's Hospital
Boston, Massachusetts, 02115
John Rolston, MD, PhDjrolston@bwh.harvard.edu
Novant Health Brain & Spine Surgery
Huntsville, North Carolina, 28708
Charles Munyon, MDcnmunyon@novanthealth.org
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Actively Recruiting
SponsorInSightec
Started2022-04-28
Est. completion2027-12
Eligibility
Age30 Years – 99 Years
Healthy vol.Accepted
Locations7 sites
View on ClinicalTrials.gov →
NCT04991831