Evaluating the safety and effectiveness of directional deep brain stimulation for Parkinson's disease

Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease

This study is testing a new brain stimulation device to see if it can help people with Parkinson's disease whose symptoms aren't well controlled by medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Pins Medical Co., Ltd (Industry-sponsored)
• Locations: 9 sites (Beijing and 8 other locations)
• Trial ID: NCT05992701 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of the PINS Deep Brain Stimulation (DBS) system for patients with Parkinson's disease whose symptoms are not adequately controlled by medication. It is a prospective, open-label, non-randomized study that will collect data on clinical outcomes, including changes in motor function and quality of life, as well as any adverse effects associated with the treatment. Key metrics will include MDS-UPDRS scores, PDQ-39 summary scores, and the total electrical energy delivered during treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with idiopathic Parkinson's disease who have not achieved adequate symptom control with medication.

Not a fit: Patients who have undergone lesioning surgical treatment or have significant cognitive impairment 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 Parkinson's disease.

How similar studies have performed: Other studies have shown promise with deep brain stimulation approaches, indicating potential for success with this novel directional technique.

Eligibility criteria

Inclusion Criteria:

1. Age at the time of enrollment: 18 \~ 75;
2. Idiopathic Parkinson's disease;
3. Patient whose symptoms are not adequately controlled by best medical therapy;
4. Hoehn and Yahr stage≥2.5;
5. Patient whose symptoms are improved by at least 30% with levodopa challenge test;
6. Must be an appropriate candidate for the surgical procedures required for bilateral DBS;
7. Is willing and able to comply with all visits and study related procedures;
8. Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

Exclusion Criteria:

1. Had received lesioning surgical treatment;
2. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception;
3. Any current drug or alcohol abuse;
4. Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle school education and above);
5. Any significant psychiatric problems, including unrelated clinically significant depression;
6. Any history of craniocerebral injury, tumor, or severe cerebrovascular disease;
7. Severe brain atrophy (confirmed by CT or MRI);
8. A condition requiring or likely to require the use of diathermy;
9. Abnormal blood routine or biochemical test, coagulation dysfunction, serious abnormal liver or kidney function;
10. Uncontrolled high blood pressure, serious heart disease or serious medical or respiratory diseases;
11. Long-term of immunosuppressive or hormone therapy;
12. Other diseases requiring the stimulators;
13. A condition requiring or likely to require the use of MRI;
14. Participated in any other clinical trials within the preceding 3 months;
15. Unwilling or unable to cooperate with the implantation of DBS system;
16. Unwilling or unable to cooperate with postoperative follow-up;
17. Not considered to be applicable by the investigator.

Where this trial is running

Beijing and 8 other locations

• Beijing Tiantan Hospital, Capital Medical University — Beijing, China (Active_not_recruiting)
• Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University — Beijing, China (Active_not_recruiting)
• West China Hospital of Sichuan University — Chengdu, China (Recruiting)
• First Affiliated Hospital of Kunming Medical University — Kunming, China (Recruiting)
• Nanjing Brain Hospital Affiliated to Nanjing Medical University — Nanjing, China (Recruiting)
• Changhai Hospital, the Second Military Medical University — Shanghai, China (Recruiting)
• Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University) — Shenzhen, China (Active_not_recruiting)
• Tianjin Medical University General Hospital — Tianjin, China (Active_not_recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, China (Active_not_recruiting)

Study contacts

• Study coordinator: Jianguang Sun

Conditions Parkinson's Disease