Registry for Exablate Neuro treatment in Parkinson's Disease
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications
This study is tracking 60 people with advanced Parkinson's Disease to see how well a new treatment using the Exablate Neuro device works for those who haven't had success with medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 99 Years |
| Sex | All |
| Sponsor | InSightec Industry-sponsored |
| Locations | 5 sites (Baltimore, Maryland and 4 other locations) |
| Trial ID | NCT05539196 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, international observational registry that aims to collect data on patients undergoing unilateral pallidotomy using the Exablate Neuro device for advanced Parkinson's Disease with medication-refractory motor complications. The registry will enroll 60 subjects across approximately 10 centers worldwide and will follow participants for 5 years, with assessments at baseline, 3, 6, and 12 months, and annually thereafter. Data collected will include adverse events, medication usage, and various patient-reported outcomes to evaluate the treatment's effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 30 years and older who are undergoing a planned Exablate procedure for their Parkinson's Disease.
Not a fit: Patients who do not agree to participate or are unlikely to complete the registry requirements will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of the Exablate Neuro treatment for patients with advanced Parkinson's Disease.
How similar studies have performed: Other studies involving similar approaches to treating Parkinson's Disease have shown promise, but this registry specifically focuses on the Exablate Neuro device post-approval.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women, age 30 years and older. * Subject undergoing a planned an Exablate procedure for their Parkinson's Disease with Motor Complications per local institution standard of care. * Subject is willing to cooperate with the Registry requirements including compliance with the regimen and completion of all Registry 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 Registry.
Where this trial is running
Baltimore, Maryland and 4 other locations
- University of Maryland, Baltimore — Baltimore, Maryland, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Ohnishi Neurological Center — Akashi, Hyōgo, Japan (Recruiting)
Study contacts
- Study coordinator: Kingsley Nwaogu
- Email: clinicalresearchquestions@insightec.com
- Phone: 2143048265
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.