Parkinson's Disease (PD)NCT06742450
Constant Current Versus Constant Voltage Subthalamic Nucleus Deep Brain Stimulation in Patients with Parkinson's Disease
A study testing Constant current (CC) subthalamic nucleus deep brain stimulation and Constant voltage (CV) subthalamic nucleus deep brain stimulation in people with Parkinson's Disease (PD), run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Constant current (CC) subthalamic nucleus deep brain stimulation and Constant voltage (CV) subthalamic nucleus deep brain stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with idiopathic Parkinson's disease
- Aged 18 to 75, no limited sex
- After bilateral STN-DBS, yet not powered on
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital of Capital Medical University
Beijing, 100053
Shanshan Mei, +86 13426263236, sophy33@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Constant current (CC) subthalamic nucleus deep brain stimulation, Constant voltage (CV) subthalamic nucleus deep brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constant current (CC) subthalamic nucleus deep brain stimulationOther
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 stimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Constant current (CC) subthalamic nucleus deep brain stimulation | Experimental | Not described Receives: Other: Constant current (CC) subthalamic nucleus deep brain stimulation |
| Constant voltage (CV) subthalamic nucleus deep brain stimulation | Active comparator | Not described Receives: Other: Constant voltage (CV) subthalamic nucleus deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change rate of MDS-UPDRS III
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.
Measured: from baseline to 6 months after surgery
Secondary outcomes (9)
MDS-UPDRS I
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.
Measured: from baseline to 6 months after surgery
MDS-UPDRS II
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.
Measured: from baseline to 6 months after surgery
MDS-UPDRS IV
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.
Measured: from baseline to 6 months after surgery
Clinical Global Impression (CGI)
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.
Measured: from baseline to 6 months after surgery
Physician satisfaction feedback
The programming physician completes a custom-made questionnaire based on their subjective judgment.
Measured: from baseline to 6 months after surgery
Patient satisfaction feedback
The patient completes a custom-made questionnaire based on their subjective judgment.
Measured: from baseline to 6 months after surgery
power consumption
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.
Measured: from baseline to 6 months after surgery
impecence
Use the programming device to measure impedance on all contacts of the IPG.
Measured: from baseline to 6 months after surgery
Adverse effects
Record any adverse events and serious adverse events during the study period.
Measured: from baseline to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start27 Jan 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742450
- Sponsor's protocol ID
- PX2024032
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Constant Current Versus Constant Voltage Deep Brain Stimulation in Patients with Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06742450
- Acronym / sponsor ID
- PX2024032
- Conditions
- Parkinson's Disease (PD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- 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
- Study start
- 27 Jan 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constant current (CC) subthalamic nucleus deep brain stimulation | Experimental | Other: Constant current (CC) subthalamic nucleus deep brain stimulation |
| Constant voltage (CV) subthalamic nucleus deep brain stimulation | Active comparator | Other: Constant voltage (CV) subthalamic nucleus deep brain stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with idiopathic Parkinson's disease
- Aged 18 to 75, no limited sex
- After bilateral STN-DBS, yet not powered on
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constant current (CC) subthalamic nucleus deep brain stimulationFor 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 current (CC) subthalamic nucleus deep brain stimulation |
| Constant voltage (CV) subthalamic nucleus deep brain stimulationFor 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. | Other | Constant voltage (CV) subthalamic nucleus deep brain stimulation |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constant current (CC) subthalamic nucleus deep brain stimulation and Constant voltage (CV) subthalamic nucleus deep brain stimulation in people with Parkinson's Disease (PD), run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Mei (+86 13426263236, sophy33@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change rate of MDS-UPDRS III (time frame: from baseline to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.