Investigating the Effects of Transcranial Direct Current Stimulation (tDCS) to Different Brain Regions on Ankle Tracking Motor Learning, Motor Adaptation, and Brain Connectivity in Healthy Middle-aged and Older Adults and Patients With Subcortical Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change of mean RMSE value of ankle tracking performances
研究概览
简要总结
Ankle control is essential to safe over-ground navigation for humans. Middle- aged and older adults and patients with stroke whose ankle control is poor often lose their balance or fall. Transcranial direct current stimulation (tDCS) is an emerging non-invasive brain stimulation technology that has great potential to be applied to neurorehabilitation; however, the optimization of its applications still needs further studies. The aims of this project are to compare the effects of anodal tDCS (AtDCS) applied to the primary motor cortex (M1) contralateral to the moving leg (cM1), posterior parietal cortex (PPC) contralateral to the moving leg (cPPC), and cerebellar cortex (CBM) ipsilateral to the moving leg (iCBM) on motor learning, motor adaptation, and brain connectivity in healthy middle-aged and older adults and hemiparetic patients with chronic subcortical stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part 1: healthy middle-aged and older adults
- •age between 40 and 80 years old
- •intact cognitive function (MMSE ≧ 27)
- •normal ankle dorsiflexor and plantarflexor strength (manual muscle strength testing= 5) and passive range of motion (ankle dorsiflexion ≧10 degrees; ankle plantarflexion ≧ 45 degrees)
- •corrected far vision ≥ 0.8 (Landolt C test) and uncorrected near vision ≥ 0.04 (Comprehensive Color Blindness Checklist)
排除标准
- •Part 1: healthy middle-aged and older adults
- •having any contraindications for MRI or tDCS;
- •serious or uncontrolled systematic diseases;
- •symptoms or history of neurological diseases, including transient ischemic attack, stroke, epilepsy, history of abnormal electroencephalogram (EEG), meningitis, encephalitis, brain tumors, brain surgery, and sensory disorders, etc.;
- •severe musculoskeletal problems that would affect lower limb functions;
- •visual spatial perception disorders and hearing loss;
- •color blindness;
- •depression and psychiatric disorders;
- •use of any medication that could affect the central nervous system function;
- •drug, substance, or alcohol addiction;
- •those participating in research involving invasive or non-invasive brain stimulation;
- •those deemed unsuitable for MRI or tDCS after evaluation by the attending physician;
- •those affiliated with any research-conducting institution.
- •Inclusion Criteria: Part 2: patients with chronic subcortical stroke
- •aged between 40 and 80 years old;
- •intact cognitive function (MMSE ≥ 27);
- •first-ever onset of subcortical stroke occurring at least 3 months prior to enrollment, with brain lesions involving unilateral subcortical regions only;
- •hemiplegic or hemiparetic;
- •no spatial neglect;
- •able to actively perform at least 5 degrees of ankle dorsiflexion and 10 degrees of ankle plantarflexion with the affected ankle;
- •no excessive spasticity;
- •no severe contracture (passive range of motion ≥ 10 degrees for ankle dorsiflexion and ≥ 20 degrees for ankle plantarflexion) in the affected leg;
- •mild-to moderate disability;
- •can walk independently or under supervision without assistance;
- •corrected far vision ≥ 0.8 (Landolt C test) and uncorrected near vision ≥ 0.04 (Comprehensive Color Blindness Checklist.)
- •Exclusion Criteria: Part 2: patients with chronic subcortical stroke The exclusion criteria will be the same as those listed for healthy participants described in Part 1 except for items (3) and (4). Item (3) will be changed to "(3a) symptoms or history of other neurological diseases, including epilepsy, history of abnormal EEG, meningitis, encephalitis, brain tumors, brain surgery, and sensory disorders, etc." and item (4) will be changed to "(4a) severe musculoskeletal problems of the non-hemiparetic limbs that would affect mobility functions".
结局指标
主要结局
Change of mean RMSE value of ankle tracking performances
时间窗: 1 week
Using a custom-built ankle tracking system
Change of Brain MRI data acquisition
时间窗: 1 week
Structural images: T1- and T2 weighted imaging, fluid attenuation inversion recovery (FLAIR) images, and diffusion spectrum image (DSI) Functional image: Resting-state functional MRI (rs-fMRI) images using a T2\* gradient echo, echo-planar sequence.
次要结局
- Mobility(1 week)
- Muscle strength of bilateral ankle dorsiflexors and plantarflexors(1 week)
- Single-task gait(1 week)
- Fall histories(1 week)
- Balance(1 week)
- Attention(1 week)
- Sensory and motor functions of patients with stroke(1 week)