Parkinson's Disease (PD)
Conditions
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.
Interventions
OTHERConstant 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.
OTHERConstant 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
Beijing Pins Medical Co., Ltd
Chinese PLA General Hospital
Tianjin Huanhu Hospital
Kunming Sanbo Brain Hospital
Xijing Hospital
The First People's Hospital of Changde City
The General Hospital of Southern Theater Command
THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY
RenJi Hospital
Changshu Hospital of Traditional Chinese Medicine
Hainan General Hospital
Affiliated Hospital of North Sichuan Medical College
Second Affiliated Hospital of Bengbu Medical College
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Patient satisfaction feedback | from baseline to 6 months after surgery | The patient completes a custom-made questionnaire based on their subjective judgment. |
Countries
China
Contacts
Primary ContactShanshan Mei
Outcome results
None listed