Registry for long-term effects of thalamotomy in Parkinson's disease patients
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
Run by InSightec · NCT04991831 · Data updated 2026-11-12
This study is tracking the long-term effects of a specific brain surgery on people with Parkinson's disease who have severe tremors and want to see how it affects their health and quality of life over five years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years to 99 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | InSightec Industry-sponsored |
| Locations | 8 sites (Miami, Florida and 7 other locations) |
| Status | Recruiting |
| Started | April 28, 2022 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT04991831 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men and women aged 30 years and older who are undergoing an Exablate procedure for tremor dominant Parkinson's Disease.
✕Probably not a fit
Patients who do not agree to participate or are unlikely to complete the study will not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry aims to gather long-term safety and effectiveness data on unilateral thalamotomy performed using the Exablate Neuro system for patients with medication-refractory tremor dominant Parkinson's Disease. Participants will have undergone the procedure prior to enrollment and will be monitored for various clinical outcomes over a period of five years. Data collected will include adverse events, medication usage, and clinical rating scales to assess tremor severity and quality of life. The study is designed to provide insights into the long-term impact of this treatment approach.
Why it matters
Potential benefit: If successful, this registry could provide valuable information on the long-term safety and effectiveness of thalamotomy, potentially improving treatment options for patients with Parkinson's disease.
How similar studies have gone: Other studies on thalamotomy for Parkinson's disease have shown promising results, indicating that this approach is supported by prior evidence.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Miami Neuroscience Institute Baptist Health
Miami, Florida, United States Recruiting -
Rush University
Chicago, Illinois, United States Recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Weill Cornell Medicine
New York, New York, United States Recruiting -
Novant Health Brain & Spine Surgery
Huntsville, North Carolina, United States Recruiting -
Cleveland Clinic Foundation
Cleveland, Ohio, United States Recruiting
Show 2 more locations
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Miami Valley Hospital
Fairborn, Ohio, United States Recruiting -
University of Dundee
Dundee, Scotland, United Kingdom Recruiting
Study contacts
- Study coordinator: Matt Hibert
- Email: clinicalresearchquestions@insightec.com
- Phone: 214-630-2000
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.