Registry for long-term effects of thalamotomy in Parkinson's disease patients
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
InSightec · NCT04991831
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 30 Years to 99 Years |
| Sex | All |
| Sponsor | InSightec (industry) |
| Locations | 8 sites (Miami, Florida and 7 other locations) |
| Trial ID | NCT04991831 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who do not agree to participate or are unlikely to complete the study will not benefit from this registry.
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 performed: Other studies on thalamotomy for Parkinson's disease have shown promising results, indicating that this approach is supported by prior evidence.
Eligibility criteria
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 this trial is running
Miami, Florida and 7 other locations
- 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)
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tremor Associated With Tremor Dominant Parkinson's Disease