RecruitingNCT05997667Updated Aug 18, 2023

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

An interventional study of Rechargeable implantable deep brain stimulation system and Rechargeable implantable deep brain stimulation system in Parkinson Disease, sponsored by Lepu Medical Technology (Beijing) Co., Ltd.. Recruiting at 7 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-18.

Sponsored by Lepu Medical Technology (Beijing) Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
Started Jul 2023; still recruiting 3 years 2 months later.

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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 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 studied

Parkinson Disease

Browse trials for

Parkinson Disease 4,487

Keywords

Rechargeable implantable deep brain stimulation (DBS) system
Parkinson's disease

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 60 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Lepu Medical Technology (Beijing) Co., Ltd. is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (estimated)

Study arms

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
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

Interventions

DeviceRechargeable 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.
DeviceRechargeable 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 researchers measure

Primary 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 off" state relative to baseline
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 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
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
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.
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
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
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.
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
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
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
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
Evaluation of equipment operational performance
The operational performance of the equipment is evaluated as excellent, good, or poor.
Time frame: Within surgery, 1 month and 3 months after surgery
Incidence of adverse events
Time frame: up to 6 months after surgery

Study locations

1 of 7 sites recruiting

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05997667
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Responsible party: Sponsor
First posted: Aug 18, 2023
Start date: Jul 20, 2023
Primary completion: Jan 20, 2025 (estimated)
Completion: Jul 20, 2025 (estimated)
Last update: Aug 18, 2023

Study contacts

Ting Zhang

Contact

ting_zhang@lepumedical.com

+86-010-80120666

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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