Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- Home PD diary
研究概览
简要总结
The objective of the CLOSE-PD study is to compare the efficacy of adaptive deep brain stimulation (aDBS) with continue deep brain stimulation (cDBS) in patients with Parkinson's disease. The main question it aims to answer is:
- whether the change in daily mean ON time without troublesome dyskinesia in aDBS is greater than cDBS over a six-month follow-up period?
Researchers will compare aDBS to regular continue deep brain stimulation (cDBS).
Participants will:
- be set up to cDBS during the first programming visit (visit 2);
- be randomized 1:1 to aDBS or cDBS two weeks after visit 2;
- follow-up will be at three and six months after visit 2;
- complete PD Home diary at baseline, two weeks, three months and at six months after visit 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
double-blinded
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
- •Diagnosis of idiopathic PD based on the UK Brain Bank criteria (Hughes et al. 1992);
- •Age older than 18 years;
- •Previous implantation of Medtronic PerceptTM PC/RC DBS electrodes bilateral targeting the STN;
- •Optimal contact point compatible with aDBS in at least one STN;
- •Reliable beta peak in at least one STN;
- •Able to provide informed consent and comply with the study protocol;
- •Understand the Dutch language.
排除标准
- •Legally incompetent adults;
- •Patients with ongoing participation in other clinical trials involving neurological interventions;
- •Inability to recognize the difference between the motor ON or OFF state;
- •Mild cognitive impairment or dementia;
- •Pregnancy.
研究组 & 干预措施
aDBS group
65 patients with Parkinson's disease will receive adaptive DBS.
干预措施: Adaptive DBS (Other)
cDBS group
65 patients with Parkinson's disease will receive continue DBS.
干预措施: Continue DBS (Other)
结局指标
主要结局
Home PD diary
时间窗: change from baseline to six months of DBS
The primary outcome is the comparison between the aDBS group and the cDBS group of the change from baseline to six months in mean daily ON time without troublesome dyskinesia. Daily ON time without troublesome dyskinesia is measured with the PD home diary. The PD home diary is a self-reported tool for tracking motor symptoms in Parkinson's patients every 30 minutes for three days within a one-week window
次要结局
- Time to final adjustment of the DBS settings(during six months of follow-up)
- PD Home diary(during six months of follow-up)
- MDS-UPDRS III (ON and OFF phase)(change from baseline to six months of DBS)
- MDS-UPDRS IV(change from baseline to six months of DBS)
- Academic Medical Center Linear Disability Score (ALDS) (ON and OFF phase)(change from baseline to six months of DBS)
- Parkinson's Disease Questionnaire 39 (PDQ-39)(change from baseline to six months of DBS)
- Dopaminergic medication usage(during six months of follow-up)
- Montreal Cognitive Assessment (MoCA)(change from baseline to six months of DBS)
- Beck Depression Inventory (BDI)(change from baseline to six months of DBS)
- Starkstein Apathy Scale (SAS)(change from baseline to six months of DBS)
- Parkinson's Disease Sleep Scale (PDSS-2)(during six months of follow-up)
- Side effects(during six months of follow-up)
- Time of DBS titration(during six months of follow-up)
- Assessor's evaluation of the ease of programming(after six months of follow-up)
- Beta oscillatory activity(during six months of follow-up)
- DBS settings (1)(during six months of follow-up)
- DBS settings (2)(during six months of follow-up)
- DBS settings (3)(during six months of follow-up)
- LFP characteristics (2)(during six months of follow-up)
- Participant's evaluation of the burden of the treatment(after six months of follow-up)
- Participant's satisfaction on the outcome of treatment(after six months of follow-up)
研究者
dr. Martijn Beudel
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)