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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Rechargeable implantable deep brain stimulation system; Device: Rechargeable implantable deep brain stimulation system

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Zhang; Phone Number: +86-010-80120666; Email: ting_zhang@lepumedical.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Xuanwu Hospital Capital Medical University
      • Contact: Yuqing Zhang
  • Fujian
    • Fuzhou, Fujian, China, 350004
      • Not yet recruiting
      • The First Affiliated Hospital of Fujian Medical University
      • Contact: Lianghong Yu
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • Not yet recruiting
      • ZhuJiang Hospital of Southern Medical University
      • Contact: Shizhong Zhang
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Not yet recruiting
      • Renmin Hospital of Wuhan University
      • Contact: Baohui Liu
  • Shaanxi
    • Xi'an, Shaanxi, China, 524001
      • Not yet recruiting
      • The Second Affiliated Hospital of Air Force Medical University
      • Contact: Xuelian Wang
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • Not yet recruiting
      • West China Hospital of Sichuan University
      • Contact: Huifang Shang
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Not yet recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Junming Zhu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-75 years old, male or female;.
2. 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%.
3. 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.
4. 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:

1. 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
2. Patients with a history of severe mental illness and a Hamilton Depression Scale (HAMD) score>24
3. Seizure history in the last 1 year
4. Patients with severe heart, liver and kidney diseases, severe hypertension and severe orthostatic hypotension that affect their health status.
5. Patients with severe diabetes or serious cardiovascular and cerebrovascular diseases that affect their health status
6. Confirmed malignant tumor
7. 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
8. Patients who have suffered a previous cranial neurological injury
9. Women who are pregnant or preparing for pregnancy
10. Patients with severe alcohol dependence and drug abuse
11. Patients who received electric shock therapy within 30 days before surgery
12. Patients who are abnormally sensitive to temperature or who are allergic to heat
13. 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.
14. Patients who are not suitable to participate in this clinical study in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Subjects in this arm will receive stimulation of DBS system within 1 month after surgery.	Device: Rechargeable implantable deep brain stimulation system; 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.; Device: Rechargeable implantable deep brain stimulation system; 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.
Other: control group; Subjects in this arm will receive stimulation of DBS system at 3 months after surgery.	Device: Rechargeable implantable deep brain stimulation system; 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.; Device: Rechargeable implantable deep brain stimulation system; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	3 and 6 months after surgery
Change in "ON" time and "OFF" time relative to the baseline		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.	6 months after surgery
Change in daily levodopa equivalent dose relative to baseline		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.	6 months after surgery
Evaluation of equipment operational performance	The operational performance of the equipment is evaluated as excellent, good, or poor.	Within surgery, 1 month and 3 months after surgery
Incidence of adverse events		up to 6 months after surgery

Collaborators and Investigators

• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): January 20, 2025
• Study Completion (Estimated): July 20, 2025

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Parkinson's disease; Rechargeable implantable deep brain stimulation (DBS) system
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: LPDBS-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No