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Recruiting NCT06742450

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

No phase Interventional Parkinson's Disease (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Constant current (CC) subthalamic nucleus deep brain stimulation, Constant voltage (CV) subthalamic nucleus deep brain stimulation.
Who it may be relevant to
Registry conditions: Parkinson's Disease (PD). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Primary outcome measures

  • The change rate of MDS-UPDRS III [Time frame: from baseline to 6 months after surgery]
Secondary outcome measures (9)
  • MDS-UPDRS I [Time frame: from baseline to 6 months after surgery]
  • MDS-UPDRS II [Time frame: from baseline to 6 months after surgery]
  • MDS-UPDRS IV [Time frame: from baseline to 6 months after surgery]
  • Clinical Global Impression (CGI) [Time frame: from baseline to 6 months after surgery]
  • Physician satisfaction feedback [Time frame: from baseline to 6 months after surgery]
  • Patient satisfaction feedback [Time frame: from baseline to 6 months after surgery]
  • power consumption [Time frame: from baseline to 6 months after surgery]
  • impecence [Time frame: from baseline to 6 months after surgery]
  • Adverse effects [Time frame: from baseline to 12 months after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xuanwu Hospital of Capital Medical University — Beijing

Identifiers

NCT: NCT06742450 · PX2024032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗