Parkinson DiseaseNCT06418802
Study of the Effects of STN-DBS on Gait in Parkinson's Disease.
A study testing STN-DBS surgery, pulse width and frequency in people with Parkinson Disease, run by Fujian Medical University Union Hospital.
Trial summary
Objectives: Parkinson's disease (PD) is the second most common degenerative disease of the nervous system. Postural instability/gait disorder (PIGD) is one of the motor symptoms of Parkinson's disease, which affects the quality of life of patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- STN-DBS surgery, pulse width and frequency
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Age 40-75 years old; (2) Patients who meet the Chinese Parkinson's disease diagnostic criteria and confirmed by two high-level physicians (>10 years); (3) Diagnosed by Parkinson's Specialty Clinic For Parkinson's disease for more than 1 year and have been effective after treatment; (4) Hearing, visual and cognitive abilities are normal; (5) The subjects were informed of the test purpose, the benefits of the test, the test process and possible unexpected situations before the test , and signed the trial informed consent form.
Who cannot join
- (1) A variety of secondary Parkinson's syndrome (including traumatic, drug-induced, tumor, vascular, toxic, hydrocephalus, etc.) and Parkinson's superimposed syndrome. (2) Other diseases that cause gait disorders, including spinal joint injuries, muscle spasm, stroke, peripheral neuropathy, muscle diseases, hydrocephalus, cognitive impairment, etc. (3) Accompanied by vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumors, unstable conditions and other serious medical diseases. (4) Those who have serious behavior problems or mental confusion. (5)Those who do not cooperate with the examination.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Series Study of the Effects of STN-DBS on Gait in Parkinson's Disease Based on Wearable Devices.
Objectives: Parkinson's disease (PD) is the second most common degenerative disease of the nervous system. Postural instability/gait disorder (PIGD) is one of the motor symptoms of Parkinson's disease, which affects the quality of life of patients with Parkinson's disease. At present, deep brain stimulation（DBS）can significantly improve tremor and bradykinesia, but whether deep brain stimulation is effective for gait disorders is still a controversial topic. In addition, the previous gait assessment mainly focused on scales or simple walking tests, and appropriate and effective evaluation methods are needed to evaluate the efficacy of intervention for gait disorders in PD patients. Therefore, in view of these problems, this study will use wearable devices and traditional scale evaluation to explore the effects of deep brain stimulation on gait in patients with Parkinson's disease.
Methods: A total of 30 patients with Subthalamic nucleus DBS（STN-DBS）were expected to be enrolled. By adjusting the parameters of STN-DBS (voltage, frequency, pulse width), the effects of different parameters on PD gait were compared. Gait changes were mainly analyzed by wearable devices and MDS Unified Parkinson's Disease Rating Scale assessment（MDS-UPDRS）. The （Timed Up and Go）TUG test, narrow channel task, circle task and trajectory analysis were performed in the unmedicated state. The wearable device was used to collect the motion information of 10 different positions of the human body, including the wrist, thigh, ankle, foot tip, chest and waist nodes. (1)Experiment 1: Patients were divided into pre-operation group and post-operation group. A case-control study was conducted, and patients were followed up at 1 month,3 months,6 months and 1 year after operation. (2)Experiment 2: This study was a single-center, randomized, double-blind, crossover trial of deep brain stimulation with a short pulse width (30s) versus conventional pulse width (60 s) in PD patients with bilateral STN-DBS. Gait data and MDS-UPDRS were collected at baseline, after 4 weeks and 8 weeks. (3)Experiment 3: By adjusting the frequency parameters of STN-DBS (30,100, and 130HZ), gait data and MDS-UPDRS were collected after 10 minutes of the washout period, and the best DBS parameters for gait improvement were maintained for 4-8 weeks and then evaluated again.
Expected results: By adjusting the parameters (voltage, frequency, and pulse width) of STN-DBS, the potential mechanisms for improving gait disorders in PD were explored, meaningful digital biomarkers for PD gait prognosis were explored, and long-term programming of STN-DBS was guided.
- Conditions
- Parkinson Disease
- Being tested
- STN-DBS surgery, pulse width, frequency
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN-DBS surgeryProcedure or surgery
bilateral subthalamic nucleus deep brain stimulation surgery
pulse widthDevice
a short pulse width (30s)
frequencyDevice
frequency parameters of STN-DBS (60,100, and 130HZ)
| Study group | Role | What they receive |
|---|---|---|
| Experiment 1: Experimental group 1 | Experimental | PD Patient's gait were followed up at 1 month,3 months,6 months, and 1 year after bilateral STN-DBS surgery. Receives: Procedure: STN-DBS surgery |
| Experiment 1: Comparator group 1 | Active comparator | PD patient's gait with optimal medical therapy before bilateral STN-DBS surgery. Receives: Procedure: STN-DBS surgery |
| Experiment 2: Experimental group 2 | Experimental | PD patient's gait with a short pulse width (30s) with bilateral STN-DBS. Receives: Device: pulse width |
| Experiment 2: Comparator group 2 | Active comparator | PD patient's gait with the conventional pulse width (60 s) with bilateral STN-DBS. Receives: Device: pulse width |
| Experiment 3: Experimental group 3 | Experimental | PD patient's gait with frequency parameters(60,100, and 130HZ) with bilateral STN-DBS. Receives: Device: frequency |
| Experiment 3: Comparator group 3 | Active comparator | PD patient's gait with the conventional frequency parameters with bilateral STN-DBS. Receives: Device: frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait data
Gait changes were analyzed by wearable devices and MDS-UPDRS.
Measured: Pre-operation（baseline)，1 month,3 months,6 months and 1 year after operation.
Gait data
Gait changes were analyzed by wearable devices and MDS-UPDRS.
Measured: Baseline, after 4 weeks and 8 weeks.
Gait data
Gait changes were analyzed by wearable devices and MDS-UPDRS.
Measured: Baseline, after 10 minutes of the washout period, after4-8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418802
- Sponsor's protocol ID
- 2023YF062-02
- Status last verified
- Mar 2024
- First submitted
- 14 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Series Study of the Effects of STN-DBS on Gait in Parkinson's Disease Based on Wearable Devices.
- ClinicalTrials.gov ID
- NCT06418802
- Acronym / sponsor ID
- 2023YF062-02
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 17 May 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.
Objectives: Parkinson's disease (PD) is the second most common degenerative disease of the nervous system. Postural instability/gait disorder (PIGD) is one of the motor symptoms of Parkinson's disease, which affects the quality of life of patients with Parkinson's disease. At present, deep brain stimulation（DBS）can significantly improve tremor and bradykinesia, but whether deep brain stimulation is effective for gait disorders is still a controversial topic. In addition, the previous gait assessment mainly focused on scales or simple walking tests, and appropriate and effective evaluation methods are needed to evaluate the efficacy of intervention for gait disorders in PD patients. Therefore, in view of these problems, this study will use wearable devices and traditional scale evaluation to explore the effects of deep brain stimulation on gait in patients with Parkinson's disease.
Methods: A total of 30 patients with Subthalamic nucleus DBS（STN-DBS）were expected to be enrolled. By adjusting the parameters of STN-DBS (voltage, frequency, pulse width), the effects of different parameters on PD gait were compared. Gait changes were mainly analyzed by wearable devices and MDS Unified Parkinson's Disease Rating Scale assessment（MDS-UPDRS）. The （Timed Up and Go）TUG test, narrow channel task, circle task and trajectory analysis were performed in the unmedicated state. The wearable device was used to collect the motion information of 10 different positions of the human body, including the wrist, thigh, ankle, foot tip, chest and waist nodes. (1)Experiment 1: Patients were divided into pre-operation group and post-operation group. A case-control study was conducted, and patients were followed up at 1 month,3 months,6 months and 1 year after operation. (2)Experiment 2: This study was a single-center, randomized, double-blind, crossover trial of deep brain stimulation with a short pulse width (30s) versus conventional pulse width (60 s) in PD patients with bilateral STN-DBS. Gait data and MDS-UPDRS were collected at baseline, after 4 weeks and 8 weeks. (3)Experiment 3: By adjusting the frequency parameters of STN-DBS (30,100, and 130HZ), gait data and MDS-UPDRS were collected after 10 minutes of the washout period, and the best DBS parameters for gait improvement were maintained for 4-8 weeks and then evaluated again.
Expected results: By adjusting the parameters (voltage, frequency, and pulse width) of STN-DBS, the potential mechanisms for improving gait disorders in PD were explored, meaningful digital biomarkers for PD gait prognosis were explored, and long-term programming of STN-DBS was guided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experiment 1: Experimental group 1 | Experimental | Procedure: STN-DBS surgeryPD Patient's gait were followed up at 1 month,3 months,6 months, and 1 year after bilateral STN-DBS surgery. |
| Experiment 1: Comparator group 1 | Active comparator | Procedure: STN-DBS surgeryPD patient's gait with optimal medical therapy before bilateral STN-DBS surgery. |
| Experiment 2: Experimental group 2 | Experimental | Device: pulse widthPD patient's gait with a short pulse width (30s) with bilateral STN-DBS. |
| Experiment 2: Comparator group 2 | Active comparator | Device: pulse widthPD patient's gait with the conventional pulse width (60 s) with bilateral STN-DBS. |
| Experiment 3: Experimental group 3 | Experimental | Device: frequencyPD patient's gait with frequency parameters(60,100, and 130HZ) with bilateral STN-DBS. |
| Experiment 3: Comparator group 3 | Active comparator | Device: frequencyPD patient's gait with the conventional frequency parameters with bilateral STN-DBS. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Age 40-75 years old; (2) Patients who meet the Chinese Parkinson's disease diagnostic criteria and confirmed by two high-level physicians (>10 years); (3) Diagnosed by Parkinson's Specialty Clinic For Parkinson's disease for more than 1 year and have been effective after treatment; (4) Hearing, visual and cognitive abilities are normal; (5) The subjects were informed of the test purpose, the benefits of the test, the test process and possible unexpected situations before the test , and signed the trial informed consent form.
Key exclusion criteria (1 listed)
- (1) A variety of secondary Parkinson's syndrome (including traumatic, drug-induced, tumor, vascular, toxic, hydrocephalus, etc.) and Parkinson's superimposed syndrome. (2) Other diseases that cause gait disorders, including spinal joint injuries, muscle spasm, stroke, peripheral neuropathy, muscle diseases, hydrocephalus, cognitive impairment, etc. (3) Accompanied by vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumors, unstable conditions and other serious medical diseases. (4) Those who have serious behavior problems or mental confusion. (5)Those who do not cooperate with the examination.
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 |
|---|---|---|
| STN-DBS surgerybilateral subthalamic nucleus deep brain stimulation surgery | Procedure or surgery | Experiment 1: Comparator group 1, Experiment 1: Experimental group 1 |
| pulse widtha short pulse width (30s) | Device | Experiment 2: Comparator group 2, Experiment 2: Experimental group 2 |
| frequencyfrequency parameters of STN-DBS (60,100, and 130HZ) | Device | Experiment 3: Comparator group 3, Experiment 3: Experimental group 3 |
Primary outcome
Gait data
Time frame: Pre-operation（baseline)，1 month,3 months,6 months and 1 year after operation.
Gait changes were analyzed by wearable devices and MDS-UPDRS.
Gait data
Time frame: Baseline, after 4 weeks and 8 weeks.
Gait changes were analyzed by wearable devices and MDS-UPDRS.
Gait data
Time frame: Baseline, after 10 minutes of the washout period, after4-8 weeks.
Gait changes were analyzed by wearable devices and MDS-UPDRS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing STN-DBS surgery, pulse width and frequency in people with Parkinson Disease, run by Fujian Medical University Union Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoen Cai (0591-18120922978, cgessmu@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait data (time frame: Pre-operation（baseline)，1 month,3 months,6 months and 1 year after operation.). The study lists 3 primary outcomes in all. 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 17 May 2024.