An Exploratory Study: The Effects of Cortical Priming on Visuomotor Stepping Learning in Healthy Adults and Persons With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Mean change from baseline in stepping motor control after five sessions of brain stimulation combined with visuomotor stepping learning
研究概览
简要总结
This research study aims to understand the relationship between brain stimulation and leg skill learning in both healthy adults and persons with chronic stroke.
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)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 21 and 90 years
- •Medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment
- •MRI or CT evidence from the imaging report shown that the stroke involves the corticospinal tract
- •Hemiparesis involving the lower extremity (Fulg-Meyer LE motor test)
- •No passive range of motion limitation in bilateral hips and knees
- •Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or less
- •Visual acuity can be corrected by glasses or contact lens to 20/20
- •Able to walk independently with/without assistant devices for 10 meters
- •Able to maintain standing position without any assistance > 30 sec (Short Physical Performance Battery)
- •Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24
排除标准
- •Pregnant women
- •MRI or CT evidence of involvement of the basal ganglia or cerebellum, evidence of multiple lesions, or evidence of any other brain damage or malignant neoplasm or tumors
- •Have any metal implants, cardiac pacemakers, or history of seizures
- •Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training
- •Any vestibular dysfunction or unstable angina
- •Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia*
研究组 & 干预措施
To explore improvements in learning capacity between healthy adults and stroke participants.
Compare stimulation-induced improvements in learning capacity between three groups: stroke group, healthy young group, and healthy older group.
干预措施: anodal transcranial direct current stimulation (a-tDCS) (Combination Product)
Explore the effects of brain stimulation on locomotor skill learning in stroke survivors
To explore the trends of locomotor skill learning in three groups: stroke survivors after five sessions of anodal tDCS (a-tDCS, real brain stimulation), stroke survivors after five sessions of sham tDCS (s-tDCS), and stroke survivors with no brain stimulation (control; CON).
干预措施: anodal transcranial direct current stimulation (a-tDCS) (Combination Product)
determine the effects of a-tDCS on the cortical excitation before and after locomotor learning
measure changes in cortical neuronal activation before and after five sessions of locomotor skill training in healthy adults and stroke participants.
干预措施: anodal transcranial direct current stimulation (a-tDCS) (Combination Product)
To explore the trends of functional improvements after five tDCS session in stroke survivors
Compare functional improvements (gait performance, balance, motor and cognitive function) between healthy adults and stroke participants after five sessions of brain stimulation.
干预措施: anodal transcranial direct current stimulation (a-tDCS) (Combination Product)
结局指标
主要结局
Mean change from baseline in stepping motor control after five sessions of brain stimulation combined with visuomotor stepping learning
时间窗: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
Stepping motor control will be quantified by the time (seconds) that each participant takes to initiate a forward step onto a visual target displayed on the wall screen.
Mean change from baseline in brain neuronal activations after five sessions of brain stimulation combined with visuomotor stepping learning
时间窗: Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training
The neuronal activations will be quantified by peak-to-peak electrical signals detected by surface electromyographic (EMG) electrodes on leg muscles after transcranial magnetic stimulations
次要结局
- Mean change from baseline in lower extremity (LE) motor function after five sessions of brain stimulation combined with visuomotor stepping learning(Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training)
- Mean change from baseline in brain neuronal network activations after five sessions of brain stimulation combined with visuomotor stepping learning(Day 1, Day 5, Day 7, Day 30, Day 60, Day 9 post five sessions of brain stimulation combined with visuomotor stepping training)