Parkinson DiseaseNCT05997667
Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease
A study testing Rechargeable implantable deep brain stimulation system in people with Parkinson Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 7 sites in China.
Trial summary
The purpose of this clinical trial is to verify the efficacy and safety of rechargeable implantable deep brain stimulation (DBS) system for the treatment of advanced primary Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rechargeable implantable deep brain stimulation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesChina
- Study dates
- 20 Jul 2023to 20 Jul 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old, male or female;.
- Primary PD (according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria for primary PD or Chinese diagnostic criteria for primary PD), with a duration of PD ≥ 4 years, and the improvement rate after an acute levodopa challenge test ≥ 30%; or primary PD, mainly characterized by tremor, the improvement of tremor by standardized drug treatment is not satisfactory and tremor is severe, which affects the patients' quality of life, after evaluation, duration can be relaxed to 3 years, the improvement rate of acute levodopa challenge test can be<30%.
- The use of levodopa once had good effects, but currently cannot satisfactorily control symptoms (significant decrease in efficacy or occurrence of fluctuations in motor function or motor dysfunction), which affects quality of life.
- Good compliance, patients and their families have the willingness to participate in the clinical trial of "bilateral implantation surgery of nervous stimulation system", voluntarily participate in this trial and sign informed consent form, patients can follow up regularly, and can accurately complete of assessment items, or the family members, guardians, or caregivers may assist the patients.
Who cannot join
- Severe cognitive impairment (MMSE score: illiterate<17, elementary school<20, junior high school or above<24), poor compliance due to dementia, and/or inability to sign informed consent form
- Patients with a history of severe mental illness and a Hamilton Depression Scale (HAMD) score>24
- Seizure history in the last 1 year
- Patients with severe heart, liver and kidney diseases, severe hypertension and severe orthostatic hypotension that affect their health status.
- Patients with severe diabetes or serious cardiovascular and cerebrovascular diseases that affect their health status
- Confirmed malignant tumor
Show all 14Show fewer
- Patients with surgical contraindications (e.g., the presence of active implants (whether turned on or not), or the presence of non-active implants that may affect the deep brain stimulation system, stereotactic nucleus lesioning, etc.), or other surgical procedures within six months that the researchers believe have an impact on this trial, or other neurosurgery contraindications
- Patients who have suffered a previous cranial neurological injury
- Women who are pregnant or preparing for pregnancy
- Patients with severe alcohol dependence and drug abuse
- Patients who received electric shock therapy within 30 days before surgery
- Patients who are abnormally sensitive to temperature or who are allergic to heat
- Subjects who are currently participating in other clinical trials or have participated in other clinical studies that have not reached the primary endpoint within three months.
- Patients who are not suitable to participate in this clinical study in the opinion of the investigator.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Yuqing Zhang
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Huifang Shang
- Not yet recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
Lianghong Yu
- Not yet recruiting
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510260
Shizhong Zhang
- Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Junming Zhu
- Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Baohui Liu
- Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 524001
Xuelian Wang
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Efficacy and Safety of Rechargeable Implantable Deep Brain Stimulation System for the Treatment of Parkinson's Disease
The purpose of this clinical trial is to verify the efficacy and safety of rechargeable implantable deep brain stimulation (DBS) system for the treatment of advanced primary Parkinson's disease.
Read the detailed description
This study is a prospective, multicenter, randomized controlled superiority clinical study. According to the unified inclusion and exclusion criteria, 60 eligible subjects are enrolled in this clinical trial. All subjects are implanted with bilateral deep brain stimulation leads, and are randomly assigned to the experimental group or control group in a 1:1 ratio. Within one month after surgery, the DBS system of experimental group is activated and the stimulation parameters are modulated, whereas the control group is not activated. The primary endpoint is the change in motor examination scores evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (MDS-UPDRS-III) in "med off" state at 3 months after surgery, compared to the baseline. After primary endpoint evaluation, both groups receive treatment with activated DBS system. The efficacy in med off/stim on and med on/stim on state and the safety are evaluated at 6 months after surgery.
- Conditions
- Parkinson Disease
- Being tested
- Rechargeable implantable deep brain stimulation system
- Keywords
- Rechargeable implantable deep brain stimulation (DBS) system, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rechargeable implantable deep brain stimulation systemDevice
The DBS system will be implanted in subjects in both study arms. Subjects in experimental group will receive stimulation of DBS system within 1 month after surgery.
Rechargeable implantable deep brain stimulation systemDevice
The DBS system will be implanted in subjects in both study arms. Subjects in control group will receive stimulation of DBS system at 3 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Subjects in this arm will receive stimulation of DBS system within 1 month after surgery. Receives: Device: Rechargeable implantable deep brain stimulation system |
| control group | Other | Subjects in this arm will receive stimulation of DBS system at 3 months after surgery. Receives: Device: Rechargeable implantable deep brain stimulation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in "med off" state relative to baseline
MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.
Measured: 3 months after surgery
Secondary outcomes (10)
Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in "med on" state relative to baseline
MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.
Measured: 3 months after surgery
Change in motor experiences of daily living score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅱ relative to baseline
MDS-UPDRS Part Ⅱ (MDS-UPDRS-Ⅱ) scores range from 0 to 52, higher scores mean a worse outcome.
Measured: 3 and 6 months after surgery
Change in non-motor experiences of daily living score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅰ relative to baseline
MDS-UPDRS Part Ⅰ (MDS-UPDRS-Ⅰ) scores range from 0 to 52, higher scores mean a worse outcome.
Measured: 3 and 6 months after surgery
Change in motor complications score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅳ relative to baseline
MDS-UPDRS Part Ⅳ (MDS-UPDRS-Ⅳ) scores range from 0 to 24, higher scores mean a worse outcome.
Measured: 3 and 6 months after surgery
Change in "ON" time and "OFF" time relative to the baseline
Measured: 3 and 6 months after surgery
Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ with stimulation in "med on" and "med off" states relative to baseline
MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.
Measured: 6 months after surgery
Change in daily levodopa equivalent dose relative to baseline
Measured: 3 and 6 months after surgery
Change in the Parkinson's Disease Questionnaire (PDQ-39) score relative to baseline
The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. Scores range from 0 to 156, higher scores mean a worse outcome.
Measured: 6 months after surgery
Evaluation of equipment operational performance
The operational performance of the equipment is evaluated as excellent, good, or poor.
Measured: Within surgery, 1 month and 3 months after surgery
Incidence of adverse events
Measured: up to 6 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 posted18 Aug 2023
- Study start20 Jul 2023
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Jul 2025 (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.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997667
- Sponsor's protocol ID
- LPDBS-2023
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Efficacy and Safety of Rechargeable Implantable Deep Brain Stimulation System for the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05997667
- Acronym / sponsor ID
- LPDBS-2023
- Conditions
- Parkinson Disease
- Keywords
- Rechargeable implantable deep brain stimulation (DBS) system, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 18 Aug 2023 (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.
The purpose of this clinical trial is to verify the efficacy and safety of rechargeable implantable deep brain stimulation (DBS) system for the treatment of advanced primary Parkinson's disease.
Detailed description
This study is a prospective, multicenter, randomized controlled superiority clinical study. According to the unified inclusion and exclusion criteria, 60 eligible subjects are enrolled in this clinical trial. All subjects are implanted with bilateral deep brain stimulation leads, and are randomly assigned to the experimental group or control group in a 1:1 ratio. Within one month after surgery, the DBS system of experimental group is activated and the stimulation parameters are modulated, whereas the control group is not activated. The primary endpoint is the change in motor examination scores evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (MDS-UPDRS-III) in "med off" state at 3 months after surgery, compared to the baseline. After primary endpoint evaluation, both groups receive treatment with activated DBS system. The efficacy in med off/stim on and med on/stim on state and the safety are evaluated at 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Rechargeable implantable deep brain stimulation systemSubjects in this arm will receive stimulation of DBS system within 1 month after surgery. |
| control group | Other | Device: Rechargeable implantable deep brain stimulation systemSubjects in this arm will receive stimulation of DBS system at 3 months after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old, male or female;.
- Primary PD (according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria for primary PD or Chinese diagnostic criteria for primary PD), with a duration of PD ≥ 4 years, and the improvement rate after an acute levodopa challenge test ≥ 30%; or primary PD, mainly characterized by tremor, the improvement of tremor by standardized drug treatment is not satisfactory and tremor is severe, which affects the patients' quality of life, after evaluation, duration can be relaxed to 3 years, the improvement rate of acute levodopa challenge test can be<30%.
- The use of levodopa once had good effects, but currently cannot satisfactorily control symptoms (significant decrease in efficacy or occurrence of fluctuations in motor function or motor dysfunction), which affects quality of life.
- Good compliance, patients and their families have the willingness to participate in the clinical trial of "bilateral implantation surgery of nervous stimulation system", voluntarily participate in this trial and sign informed consent form, patients can follow up regularly, and can accurately complete of assessment items, or the family members, guardians, or caregivers may assist the patients.
Key exclusion criteria (14 listed)
- Severe cognitive impairment (MMSE score: illiterate<17, elementary school<20, junior high school or above<24), poor compliance due to dementia, and/or inability to sign informed consent form
- Patients with a history of severe mental illness and a Hamilton Depression Scale (HAMD) score>24
- Seizure history in the last 1 year
- Patients with severe heart, liver and kidney diseases, severe hypertension and severe orthostatic hypotension that affect their health status.
- Patients with severe diabetes or serious cardiovascular and cerebrovascular diseases that affect their health status
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 |
|---|---|---|
| Rechargeable implantable deep brain stimulation systemThe DBS system will be implanted in subjects in both study arms. Subjects in experimental group will receive stimulation of DBS system within 1 month after surgery. | Device | experimental group |
| Rechargeable implantable deep brain stimulation systemThe DBS system will be implanted in subjects in both study arms. Subjects in control group will receive stimulation of DBS system at 3 months after surgery. | Device | control group |
Primary outcome
Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in "med off" state relative to baseline
Time frame: 3 months after surgery
MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.
10 secondary outcomes
Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in "med on" state relative to baseline
Time frame: 3 months after surgery
Change in motor experiences of daily living score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅱ relative to baseline
Time frame: 3 and 6 months after surgery
Change in non-motor experiences of daily living score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅰ relative to baseline
Time frame: 3 and 6 months after surgery
Change in motor complications score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅳ relative to baseline
Time frame: 3 and 6 months after surgery
Change in "ON" time and "OFF" time relative to the baseline
Time frame: 3 and 6 months after surgery
Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ with stimulation in "med on" and "med off" states relative to baseline
Time frame: 6 months after surgery
Change in daily levodopa equivalent dose relative to baseline
Time frame: 3 and 6 months after surgery
Change in the Parkinson's Disease Questionnaire (PDQ-39) score relative to baseline
Time frame: 6 months after surgery
Evaluation of equipment operational performance
Time frame: Within surgery, 1 month and 3 months after surgery
Incidence of adverse events
Time frame: up to 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rechargeable implantable deep brain stimulation system in people with Parkinson Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 7 sites 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 4 inclusion and 14 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Zhang (+86-010-80120666, ting_zhang@lepumedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in "med off" state relative to baseline (time frame: 3 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 18 Aug 2023.