NCT04744493

A Clinical Trial for the Safety and Effect of MRGuided FUS Subthalamotomy for Medication Refractory Parkinson's Disease

A Clinical Trial for Evaluation of the Safety and Effect of MR-guided FUS Subthalamotomy for Medication-refractory Parkinson's Disease Motor Features

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Study design: This is a prospective, open-label, single-center, and sponsor-initiated clinical trial. The clinical trial follows the Clinical Investigation Plan, GCP. Objective: The objective of the clinical trial is to evaluate improving Parkinson's disease motor features by MR-guided focused ultrasound surgery (Patient who has less effectiveness.).

Detailed description

Endpoint: All PD003J treated subjects will be followed up for 4 months. The primary endpoints will be safety of unilateral, PD003J subthalamotomy for PD. The endpoint will be determined from adverse events recorded during the 4 months period for safety. Secondary endpoints will include changes in MDS-UPDRS, levodopa equivalent medication, Global Impression of Change and so on. Primary endpoint of safety: Incidence and severity of adverse events (AE/AEs) associated with PD003J treatment of idiopathic PD at 4 months post treatment. Safety will be evaluated individually for each subject who is treated. An analysis of safety will be performed on all treated subjects and will be determined by an evaluation of the incidence and severity of device- and procedure-related complications. In particular, in this study, the incidence of severe involuntary movements (one-sided ballism) is confirmed. All AEs will be reported and categorized by investigators as definitely, probably, possibly, unlikely, or unrelated to the device, subthalamotomy procedure, and/or Parkinson's disease progression. Secondary endpoints: Secondary endpoints will include both comparison of baseline to 1 week visit, 2-month visit and baseline to 4-month visit assessments for the following: • MDS-UPDRS parts I, II, III, and IV • Levodopa equivalent medication usage (milligrams) • Patient and Physician Global Impression of Change • Patient Satisfaction Questionnaire.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	ExaBlate 4000	The Exablate 4000, an advanced, non-invasive technique for performing ablation of the Thalamus for treating Essential Tremor, received FDA PMA (P150038) approval for unilateral treatment of Essential Tremor in 2016.

Timeline

• Start date: 2019-05-31
• Primary completion: 2022-05-31
• Completion: 2022-07-31
• First posted: 2021-02-09
• Last updated: 2024-03-06

Locations

1 site across 1 country: Japan