Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04744493
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2020-09-23
Brief Title:
A Clinical Trial for the Safety and Effect of MRGuided FUS Subthalamotomy for Medication Refractory Parkinsons Disease
Sponsor:
InSightec
Organization:
InSightec
Study Overview
Official Title:
A Clinical Trial for Evaluation of the Safety and Effect of MR-guided FUS Subthalamotomy for Medication-refractory Parkinsons Disease Motor Features
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Parkinsons 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 AEAEs 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 andor Parkinsons 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
Primary endpoint of safety Incidence and severity of adverse events AEAEs 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 andor Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None