Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
Study NCT ID:
NCT06742450
Status:
RECRUITING
Last Update Posted:
2024-12-19
First Post:
2024-12-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Constant Current Versus Constant Voltage Subthalamic Nucleus Deep Brain Stimulation in Patients with Parkinson's Disease
Sponsor:
Xuanwu Hospital, Beijing
Organization:
Study Overview
Official Title:
Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease
Status:
RECRUITING
Status Verified Date:
2024-12
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:
To compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery.
Detailed Description:
This is a randomized, parallel controlled, multi-center study to compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery. Participants will be followed for up to 12 months. Approximately 180 PD participants will be recruited from up to 14 sites. Participants will be randomized to current mode or voltage mode after DBS surgery and be comprehensively assessed at baseline and follow up according to the protocol developed.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: