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

NCT06742450 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-12-19

No results posted yet for this study

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.

Conditions

  • Parkinson's Disease (PD)

Interventions

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.

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.

Sponsors & Collaborators

  • Beijing Pins Medical Co., Ltd

    collaborator INDUSTRY
  • Chinese PLA General Hospital

    collaborator OTHER
  • Tianjin Huanhu Hospital

    collaborator OTHER
  • Kunming Sanbo Brain Hospital

    collaborator UNKNOWN
  • Xijing Hospital

    collaborator OTHER
  • The First People's Hospital of Changde City

    collaborator OTHER
  • The General Hospital of Southern Theater Command

    collaborator OTHER
  • THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY

    collaborator UNKNOWN
  • RenJi Hospital

    collaborator OTHER
  • Changshu Hospital of Traditional Chinese Medicine

    collaborator OTHER
  • Hainan General Hospital

    collaborator OTHER
  • Affiliated Hospital of North Sichuan Medical College

    collaborator OTHER
  • Second Affiliated Hospital of Bengbu Medical College

    collaborator OTHER
  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-27
Primary Completion
2026-03-31
Completion
2026-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06742450 on ClinicalTrials.gov