Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT05997667
Status:
UNKNOWN
Last Update Posted:
2023-08-18
First Post:
2023-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease
Sponsor:
Lepu Medical Technology (Beijing) Co., Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Efficacy and Safety of Rechargeable Implantable Deep Brain Stimulation System for the Treatment of Parkinson's Disease
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
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:
The purpose of this clinical trial is to verify the efficacy and safety of rechargeable implantable deep brain stimulation (DBS) system for the treatment of advanced primary Parkinson's disease.
Detailed Description:
This study is a prospective, multicenter, randomized controlled superiority clinical study. According to the unified inclusion and exclusion criteria, 60 eligible subjects are enrolled in this clinical trial. All subjects are implanted with bilateral deep brain stimulation leads, and are randomly assigned to the experimental group or control group in a 1:1 ratio. Within one month after surgery, the DBS system of experimental group is activated and the stimulation parameters are modulated, whereas the control group is not activated. The primary endpoint is the change in motor examination scores evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (MDS-UPDRS-III) in "med off" state at 3 months after surgery, compared to the baseline. After primary endpoint evaluation, both groups receive treatment with activated DBS system. The efficacy in med off/stim on and med on/stim on state and the safety are evaluated at 6 months after surgery.
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?: