A Neural Basis for Cognitive Decline Following Deep Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Brain Microstructure (DKI)
研究概览
简要总结
This research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo four visits, including a 1-hour screening visit, a 1.5-hour pre-DBS MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.
详细描述
Deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) is a well-established surgical intervention to treat Parkinson's Disease (PD) patients with disabling motor fluctuations and dyskinesias. Although this therapy is effective for motor complications, a subset of patients will go on to experience cognitive decline, which can overshadow improvements in the quality of life provided by STN-DBS. This accelerated decline in cognition occurs in patients despite rigorous evaluation of their neuropsychological status prior to surgery. While the factors contributing to cognitive decline following DBS remain unclear, there is evidence this may be the result of 1) limited cognitive reserve prior to DBS surgery, 2) stimulation that interferes with cognitive networks, and/or 3) a microlesion effect due to placement of the lead. Understanding how these factors contribute to DBS-induced cognitive decline has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PD Participants
- •Inclusion Criteria:
- •Subjects above 18 years of age
- •Subjects who will undergo DBS surgery as part of their clinical care for PD
排除标准
- •Uncorrected visual or hearing impairments, as indicated by self-report
- •Individuals who are pregnant or expect to become pregnant during the course of the study
- •Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
- •COPD with oxygen dependence
- •Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)
- •Non-PD Control Participants
- •Inclusion Criteria:
- •Subjects above 18 years of age
- •Age matched to participants in PD group
- •Exclusion Criteria:
- •Diagnosis of Parkinsons Disease or other movement disorder
- •Untreated neuropsychiatric disorders
- •Uncorrected visual or hearing impairments, as indicated by self-report
- •Individuals who are pregnant or expect to become pregnant during the course of the study
- •Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
- •COPD with oxygen dependence
- •Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)
结局指标
主要结局
Brain Microstructure (DKI)
时间窗: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion kurtosis imaging (mean kurtosis; MK)
Change in Cognition
时间窗: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery
Change in cognitive performance using a comprehensive neuropsychological battery (e.g., language, executive control, memory, and attention)
次要结局
- Brain Microstructure (DTI)(Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS)))
- Brain Functional Connectivity(Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS)))