Clinical trial NCT05997667: 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
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Rechargeable implantable deep brain stimulation (DBS) system
Parkinson's disease
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: 3 months after surgery
Secondary outcomes:
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 on" state relative to baseline
timeFrame: 3 months after surgery
measure: 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
timeFrame: 3 and 6 months after surgery
measure: 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
timeFrame: 3 and 6 months after surgery
measure: 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
timeFrame: 3 and 6 months after surgery
measure: Change in "ON" time and "OFF" time relative to the baseline
timeFrame: 3 and 6 months after surgery
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 with stimulation in "med on" and "med off" states relative to baseline
timeFrame: 6 months after surgery
measure: Change in daily levodopa equivalent dose relative to baseline
timeFrame: 3 and 6 months after surgery
measure: Change in the Parkinson's Disease Questionnaire (PDQ-39) score relative to baseline
timeFrame: 6 months after surgery
measure: Evaluation of equipment operational performance
timeFrame: Within surgery, 1 month and 3 months after surgery
measure: Incidence of adverse events
timeFrame: up to 6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: ZhuJiang Hospital of Southern Medical University
state: Guangdong
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Air Force Medical University
state: Shaanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: