Udall Project 1 Aim 4
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cognitive outcome 3 association with pathway activation pattern
研究概览
简要总结
By defining the strength and direction of connectivity patterns at rest and during movement across the basal ganglia-thalamocortical (BGTC) network we will characterize the role of individual circuits in motor performance and cognitive function, paving the way for future development of optimization algorithms for DBS that take advantage of this understanding.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implanted with a DBS system
- •Existing 7T imagery (either done as standard-of-care or done as part of Noam Harel's study, IRB #1210M22183)
- •Diagnosed with idiopathic Parkinson's Disease
- •Minimum age 21 years
排除标准
- •Other significant neurological disorder, as determined by PI
- •Diagnosis of dementia
研究组 & 干预措施
Group 1
Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions:
- clinically-optimized stimulation
- model-based stimulation directed towards motor subregions of STN and GPi
- model-based stimulation directed towards associative/limbic subregions of STN/GPi
Randomized to start with condition1 assessment
Group 2
Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions:
- clinically-optimized stimulation
- model-based stimulation directed towards motor subregions of STN and GPi
- model-based stimulation directed towards associative/limbic subregions of STN/GPi
Randomized to start with condition 2 assessment
Group 3
Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions:
- clinically-optimized stimulation
- model-based stimulation directed towards motor subregions of STN and GPi
- model-based stimulation directed towards associative/limbic subregions of STN/GPi
Randomized to start with condition 3 assessment
结局指标
主要结局
Cognitive outcome 3 association with pathway activation pattern
时间窗: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will include the Beck Depression Inventory (BDI)-II
Cognitive outcome 1 association with pathway activation pattern
时间窗: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. One primary cognitive outcome measure will be the D-KEFS Letter Fluency test. Another primary cognitive measure will be the Stroop Color Word total score. Secondary measures will include the Beck Depression Inventory (BDI)-II and Apathy Scale total scores.
Motor association with pathway activation patterns
时间窗: 6 months post surgery
associate pathway activation patterns with motor (UPDRS-III) outcome obtained during standard of care and research appointments.
Cognitive outcome 2 association with pathway activation pattern
时间窗: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will be the Stroop Color Word total score.
Cognitive outcome 4 association with pathway activation pattern
时间窗: 6 months post surgery
associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments. cognitive measure will include the Apathy Scale total scores.
次要结局
未报告次要终点