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NCT Number: NCT06742450

Constant Current Versus Constant Voltage Subthalamic Nucleus 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.

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Key information

Conditions

Parkinson's Disease (PD)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital of Capital Medical University

Beijing, 100053, China

Location status: Recruiting

Location contact

Shanshan Mei

CONTACT

[email protected]

+86 13426263236

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Constant current (CC) subthalamic nucleus deep brain stimulation

Other

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.

Constant voltage (CV) subthalamic nucleus deep brain stimulation

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Patient satisfaction feedback

    Time frame: from baseline to 6 months after surgery

    The patient completes a custom-made questionnaire based on their subjective judgment.

  7. 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.

  8. impecence

    Time frame: from baseline to 6 months after surgery

    Use the programming device to measure impedance on all contacts of the IPG.

  9. Adverse effects

    Time frame: from baseline to 12 months after surgery

    Record any adverse events and serious adverse events during the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Shanshan Mei

CONTACT

[email protected]

+86 13426263236

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Affiliated Hospital of North Sichuan Medical College
  • Beijing Pins Medical Co., Ltd
  • Changshu Hospital of Traditional Chinese Medicine
  • Chinese PLA General Hospital
  • Hainan General Hospital
  • Kunming Sanbo Brain Hospital
  • RenJi Hospital
  • Second Affiliated Hospital of Bengbu Medical College
  • The First Affilated Hospital of the Medical College, Shihezi University
  • The First People's Hospital of Changde City
  • The General Hospital of Southern Theater Command
  • Tianjin Huanhu Hospital
  • Xijing Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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