Constant Current Versus Constant Voltage Subthalamic Nucleus Deep Brain Stimulation in Patients with Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson's Disease (PD)

• Registration Number: NCT06742450
• Lead Sponsor: Xuanwu Hospital, Beijing

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 Timeline

• Study Start: 2024-01-27
• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2026-03-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The change rate of MDS-UPDRS III	from baseline to 6 months after surgery	MDS-UPDRS III is the motor examination section of the MDS-UPDRS (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale), completed by the evaluator, providing an objective assessment of motor symptoms in patients with Parkinson's disease. MDS-UPDRS III ranges from 0-132. The change rate of MDS-UPDRS III in the Stim-On/Med-On state from baseline to 6 months after surgery will be collected. Positive indicates improvement.

Secondary Outcome Measures

Name	Time	Method
MDS-UPDRS I	from baseline to 6 months after surgery	MDS-UPDRS I is the non-motor experiences of daily living section of the MDS-UPDRS (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale). Subsection IA is evaluated by the researcher based on all relevant information provided by the patient or their caregiver regarding certain symptoms. Subsection IB is completed by the patient, with assistance from the caregiver if needed, but it must not be completed by the researcher. The change rate of MDS-UPDRS I from baseline to 6 months after surgery will be collected.
MDS-UPDRS II	from baseline to 6 months after surgery	MDS-UPDRS II is the motor experiences of daily living section of the MDS-UPDRS (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale) and is a self-reported questionnaire completed by the patient. The change rate of MDS-UPDRS II from baseline to 6 months after surgery will be collected.
MDS-UPDRS IV	from baseline to 6 months after surgery	MDS-UPDRS IV is the motor complications section of the MDS-UPDRS (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale). This section is rated by the evaluator, combining information provided by the patient with the evaluator's clinical observation and judgment to generate a comprehensive score. The change rate of MDS-UPDRS IV from baseline to 6 months after surgery will be collected.
Clinical Global Impression (CGI)	from baseline to 6 months after surgery	The Clinical Global Impression (CGI) is a global assessment scale initially designed by the World Health Organization (WHO) for use in IPSS research to evaluate clinical efficacy. It provides an overall measure of treatment outcomes.
Physician satisfaction feedback	from baseline to 6 months after surgery	The programming physician completes a custom-made questionnaire based on their subjective judgment.
Patient satisfaction feedback	from baseline to 6 months after surgery	The patient completes a custom-made questionnaire based on their subjective judgment.
power consumption	from baseline to 6 months after surgery	The total power consumption of the patient's IPG between visits is calculated. During follow-up, device logs are uploaded from the charging equipment to the database. The raw data is then retrieved from the database.
impecence	from baseline to 6 months after surgery	Use the programming device to measure impedance on all contacts of the IPG.
Adverse effects	from baseline to 12 months after surgery	Record any adverse events and serious adverse events during the study period.

Trial Locations

Locations (1)

Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, China