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

December 16, 2024 updated by: Xuanwu Hospital, Beijing

Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital of Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Constant current (CC) subthalamic nucleus deep brain stimulation
Other: Constant current (CC) subthalamic nucleus deep brain stimulation
For subjects who have decided to undergo STN-DBS surgery and meet the inclusion criteria, the constant current (CC) mode is selected as the original electronic modality one week after surgery. Regardless of any changes in programming parameters over the following year, the constant current (CC) mode will be maintained.
Active Comparator: Constant voltage (CV) subthalamic nucleus deep brain stimulation
Other: Constant voltage (CV) subthalamic nucleus deep brain stimulation
For subjects who have decided to undergo STN-DBS surgery and meet the inclusion criteria, the constant voltage (CV) mode is selected as the original electronic modality one week after surgery. Regardless of any changes in programming parameters over the following year, the constant voltage (CV) mode will be maintained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change rate of MDS-UPDRS III
Time Frame: 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.
from baseline to 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-UPDRS I
Time Frame: 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.
from baseline to 6 months after surgery
MDS-UPDRS II
Time Frame: 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.
from baseline to 6 months after surgery
MDS-UPDRS IV
Time Frame: 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.
from baseline to 6 months after surgery
Clinical Global Impression (CGI)
Time Frame: 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.
from baseline to 6 months after surgery
Physician satisfaction feedback
Time Frame: from baseline to 6 months after surgery
The programming physician completes a custom-made questionnaire based on their subjective judgment.
from baseline to 6 months after surgery
Patient satisfaction feedback
Time Frame: from baseline to 6 months after surgery
The patient completes a custom-made questionnaire based on their subjective judgment.
from baseline to 6 months after surgery
power consumption
Time Frame: 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.
from baseline to 6 months after surgery
impecence
Time Frame: from baseline to 6 months after surgery
Use the programming device to measure impedance on all contacts of the IPG.
from baseline to 6 months after surgery
Adverse effects
Time Frame: from baseline to 12 months after surgery
Record any adverse events and serious adverse events during the study period.
from baseline to 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Collaborators

Xijing Hospital
Chinese PLA General Hospital
RenJi Hospital
Hainan General Hospital
Beijing Pins Medical Co., Ltd
Affiliated Hospital of North Sichuan Medical College
Tianjin Huanhu Hospital
Second Affiliated Hospital of Bengbu Medical College
The First People's Hospital of Changde City
Changshu Hospital of Traditional Chinese Medicine
The General Hospital of Southern Theater Command
THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY
Kunming Sanbo Brain Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PX2024032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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