Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 9
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms. Researchers will compare closed-loop stimulation (which automatically adjusts therapy using real-time brain signals and sleep monitoring) against traditional continuous stimulation (fixed settings) in a randomized, double-blind, crossover study. Participants will undergo surgical implantation of PINS Medical's G1010R neurostimulator, followed by alternating treatment phases where each patient experiences both aDBS and conventional open-loop stimulation modes. Outcomes will assess improvements in without troublesome dyskinesia daily time, motor symptoms (e.g., tremors, rigidity), quality of life, and sleep quality across both therapy periods.
详细描述
The goal of this clinical trial is to evaluate the efficacy and safety of PINS Medical's rechargeable implantable closed-loop deep brain stimulation (aDBS) system for improving quality of life in Parkinson's disease patients. Researchers will compare adaptive closed-loop stimulation (which automatically adjusts therapy using real-time brain signals) against conventional open-loop stimulation (cDBS) in a prospective, multicenter, double-blind, randomized crossover study. Participants will undergo surgical implantation of the neurostimulator system and progress through five trial phases: screening/surgery, cDBS optimization, aDBS optimization, crossover evaluation, and long-term follow-up across nine visits. During crossover testing, each participant will experience both stimulation modes sequentially while blinded. Key outcomes include duration of troublesome/non-troublesome dyskinesia, "off" time, sleep scales (VAS, PDSS-2, PSQI), motor symptoms (MDS-UPDRS), quality of life (PDQ-39, EQ-5D-5L), and safety parameters. The primary analysis will occur after all randomized subjects complete crossover testing and unblinding (Visit 7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking starts at the moment when randomization is completed and ends at the end of crossover phases.
Only the investigator who is responsible for configuring, adjusting, and optimizing stimulation parameters throughout all trial phases is not blinded.
Masking is conducted by software setup. Anyone having access to the programming device (tablet) is unable to see whether adaptive stimulation mode is turned on or off unless knowing the password and the entry to this info.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic Parkinson's disease
- •Hoehn & Yahr (HY) stage 2.5-4 during medication "OFF"
- •Subjects must meet one of the following:
- •Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;
- •Previous bilateral STN/GPi DBS recipients with only one IPG who:
- •Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,
- •Consent to device replacement with G1010R DBS system.
- •Willing and physically/mentally able to complete all study visits and procedures
- •Capable of comprehending and providing written informed consent
排除标准
- •Presence of contraindications to deep brain stimulation (DBS) surgery.
- •Beck Depression Inventory-II (BDI-II) score > 25
- •Mini-Mental State Examination (MMSE) score < 24 (adjusted for educational level)
- •Significant comorbidities that may interfere with DBS therapy per investigator assessment.
- •Pre-existing active non-DBS medical implants or metallic cranial implants
- •Requirement for diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT) during the study period
- •History of ablative neurosurgery or stem cell therapy for Parkinson's disease
- •Inability to complete ≥3 consecutive days of comprehensive motor/sleep diaries
- •Inability to maintain prescribed medication regimens or comply with protocol requirements
- •Current pregnancy, lactation, or planned pregnancy during the study period
- •Other conditions deemed by investigators to compromise study suitability
- •Participation in other interventional clinical trials within 4 weeks prior to consent
研究组 & 干预措施
Group B
Participants in this group will first take adaptive DBS treatment for 30-45 days, then change to conventional DBS treatment for another 30-45 days.
干预措施: conventional deep brain stimulation (Device)
Group A
Participants in this group will first take conventional DBS treatment for 30-45 days, then change to adaptive DBS treatment for another 30-45 days.
干预措施: adaptive deep brain stimulation (Device)
Group A
Participants in this group will first take conventional DBS treatment for 30-45 days, then change to adaptive DBS treatment for another 30-45 days.
干预措施: conventional deep brain stimulation (Device)
Group B
Participants in this group will first take adaptive DBS treatment for 30-45 days, then change to conventional DBS treatment for another 30-45 days.
干预措施: adaptive deep brain stimulation (Device)