Rechargeable implantable device for treating 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

This study is testing a new rechargeable device to see if it can help people with advanced Parkinson's disease feel better by using deep brain stimulation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Lepu Medical Technology (Beijing) Co., Ltd. (Industry-sponsored)
• Locations: 7 sites (Beijing, Beijing and 6 other locations)
• Trial ID: NCT05997667 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of a rechargeable implantable deep brain stimulation (DBS) system for patients with advanced primary Parkinson's disease. It is a multicenter, randomized controlled trial involving 60 participants who will receive bilateral DBS leads and be assigned to either an experimental group with activated stimulation or a control group without activation. The primary outcome will be assessed using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III at three months post-surgery, with further evaluations at six months. Both groups will eventually receive activated DBS treatment after the primary endpoint assessment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced primary Parkinson's disease who have not achieved satisfactory symptom control with levodopa.

Not a fit: Patients with early-stage Parkinson's disease or those who do not respond to levodopa treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve motor function and quality of life for patients with advanced Parkinson's disease.

How similar studies have performed: Previous studies on deep brain stimulation have shown promising results in improving symptoms of Parkinson's disease, indicating a potential for success with this approach.

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.

Where this trial is running

Beijing, Beijing and 6 other locations

• Xuanwu Hospital Capital Medical University — Beijing, Beijing, China (Recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• ZhuJiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Air Force Medical University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Ting Zhang

Conditions Parkinson Disease; Rechargeable implantable deep brain stimulation system; Parkinson's disease