Clinical trial NCT06742450: Constant Current Versus Constant Voltage Subthalamic Nucleus Deep Brain Stimulation in Patients with Parkinson's Disease
Official title: Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson&#39;s Disease (PD)
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Pins Medical Co., Ltd
name: Chinese PLA General Hospital
name: Tianjin Huanhu Hospital
name: Kunming Sanbo Brain Hospital
name: Xijing Hospital
name: The First People's Hospital of Changde City
name: The General Hospital of Southern Theater Command
name: THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY
name: RenJi Hospital
name: Changshu Hospital of Traditional Chinese Medicine
name: Hainan General Hospital
name: Afﬁliated Hospital of North Sichuan Medical College
name: Second Affiliated Hospital of Bengbu Medical College
First posted: 2024-12-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic Parkinson's disease
* Aged 18 to 75, no limited sex
* After bilateral STN-DBS, yet not powered on

Exclusion Criteria:

* Mental disorders or dementia
* Pregnant, lactating women or women who are unable to take effective measures to prevent pregnancy
* Serious health conditions, such as tumors, liver or kidney diseases, etc.
* Epilepsy or other seizure disorders
* Patients with severely deviated electrode placement
* Patients who were unable to voluntarily sign an informed consent form
* Patients who did not agree to cooperate with follow-up

Primary outcomes:
measure: The change rate of MDS-UPDRS III
timeFrame: from baseline to 6 months after surgery
Secondary outcomes:
measure: MDS-UPDRS I
timeFrame: from baseline to 6 months after surgery
measure: MDS-UPDRS II
timeFrame: from baseline to 6 months after surgery
measure: MDS-UPDRS IV
timeFrame: from baseline to 6 months after surgery
measure: Clinical Global Impression (CGI)
timeFrame: from baseline to 6 months after surgery
measure: Physician satisfaction feedback
timeFrame: from baseline to 6 months after surgery
measure: Patient satisfaction feedback
timeFrame: from baseline to 6 months after surgery
measure: power consumption
timeFrame: from baseline to 6 months after surgery
measure: impecence
timeFrame: from baseline to 6 months after surgery
measure: Adverse effects
timeFrame: from baseline to 12 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital of Capital Medical University
Study officials:
References: