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Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rechargeable implantable deep brain stimulation system
Rechargeable implantable deep brain stimulation system
Sponsored by
Lepu Medical Technology (Beijing) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Rechargeable implantable deep brain stimulation (DBS) system, Parkinson's disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Sites / Locations

  • Xuanwu Hospital Capital Medical UniversityRecruiting
  • The First Affiliated Hospital of Fujian Medical University
  • ZhuJiang Hospital of Southern Medical University
  • Renmin Hospital of Wuhan University
  • The Second Affiliated Hospital of Air Force Medical University
  • West China Hospital of Sichuan University
  • The Second Affiliated Hospital Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

experimental group

control group

Arm Description

Subjects in this arm will receive stimulation of DBS system within 1 month after surgery.

Subjects in this arm will receive stimulation of DBS system at 3 months after surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Change in "ON" time and "OFF" time relative to the baseline
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.
Change in daily levodopa equivalent dose relative to baseline
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.
Evaluation of equipment operational performance
The operational performance of the equipment is evaluated as excellent, good, or poor.
Incidence of adverse events

Full Information

First Posted
August 7, 2023
Last Updated
August 15, 2023
Sponsor
Lepu Medical Technology (Beijing) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05997667
Brief Title
Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
January 20, 2025 (Anticipated)
Study Completion Date
July 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lepu Medical Technology (Beijing) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Rechargeable implantable deep brain stimulation (DBS) system, Parkinson's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Subjects in this arm will receive stimulation of DBS system within 1 month after surgery.
Arm Title
control group
Arm Type
Other
Arm Description
Subjects in this arm will receive stimulation of DBS system at 3 months after surgery.
Intervention Type
Device
Intervention Name(s)
Rechargeable implantable deep brain stimulation system
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Rechargeable implantable deep brain stimulation system
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
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
Description
MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.
Time Frame
3 months after surgery
Title
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
Description
MDS-UPDRS Part Ⅱ (MDS-UPDRS-Ⅱ) scores range from 0 to 52, higher scores mean a worse outcome.
Time Frame
3 and 6 months after surgery
Title
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
Description
MDS-UPDRS Part Ⅰ (MDS-UPDRS-Ⅰ) scores range from 0 to 52, higher scores mean a worse outcome.
Time Frame
3 and 6 months after surgery
Title
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
Description
MDS-UPDRS Part Ⅳ (MDS-UPDRS-Ⅳ) scores range from 0 to 24, higher scores mean a worse outcome.
Time Frame
3 and 6 months after surgery
Title
Change in "ON" time and "OFF" time relative to the baseline
Time Frame
3 and 6 months after surgery
Title
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
Description
MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.
Time Frame
6 months after surgery
Title
Change in daily levodopa equivalent dose relative to baseline
Time Frame
3 and 6 months after surgery
Title
Change in the Parkinson's Disease Questionnaire (PDQ-39) score relative to baseline
Description
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.
Time Frame
6 months after surgery
Title
Evaluation of equipment operational performance
Description
The operational performance of the equipment is evaluated as excellent, good, or poor.
Time Frame
Within surgery, 1 month and 3 months after surgery
Title
Incidence of adverse events
Time Frame
up to 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Zhang
Phone
+86-010-80120666
Email
ting_zhang@lepumedical.com
Facility Information:
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuqing Zhang
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350004
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lianghong Yu
Facility Name
ZhuJiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shizhong Zhang
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baohui Liu
Facility Name
The Second Affiliated Hospital of Air Force Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
524001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuelian Wang
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huifang Shang
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junming Zhu

12. IPD Sharing Statement

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Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease

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