Neural Network Reorganization Associated With Upper Limb Motor Recovery in Stroke Patients- Establishing a Prognostic Model and Tailoring Neuromodulation for Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change of muscle spasticity using Modified Ashworth scale for spasticity (MAS)
研究概览
简要总结
This main aim of the study is to investigate the changes in neurophysiological features after stroke, and its association with upper limb motor recovery, so as to establish a prognostic model for upper limb motor recovery after stroke. The investigators hypothesize that a combination of neurophysiological features measured by transcranial magnetic stimulation (TMS), high density electroencephalography (HD-EEG), functional magnetic resonance imaging (fMRI) and Diffusion Tensor Imaging (DTI) might be used as biomarkers to predict upper limb motor outcomes after stroke. The investigators also hypothesize that non-invasive brain stimulation strategies such as tDCS will more effectively improve motor outcomes as an adjunct to therapy, if tailored according to patient's predicted pattern of neural reorganization.
详细描述
This study comprises 2 parts. Study 1 is a longitudinal cohort study to characterize the neurophysiological changes with upper limb motor recovery in stroke patients with moderate to severe upper limb motor function impairment, and its correlation with motor function recovery.
120 stroke subjects within 3 weeks post-stroke will be recruited from National University Hospital (NUH), Alexandra Hospital (AH), and Tan Tock Seng Hospital (TTSH). We will follow changes in cortical activity over time using Transcranial Magnetic Stimulation (TMS), MRI and EEG measures and correlate these with clinical outcome measures at the same time points, to study the interaction between neural excitability and functional outcome.
10 healthy subjects will be needed as control group to compare outcomes obtained from MRI scans.
Outcome measures of brain corticospinal excitability, clinical measures on upper limb motor function and cognitive tests, will be performed 4 times- within 4 weeks, at 3 months, 6 months and 1 year after stroke onset, except for MRI which will not be performed at 1 year after stroke onset.
Subjects from Study 1 whose ARAT (Action Research Arm test) score is < = 42 at 3 months post-stroke will proceed to Study 2. ARAT score < = 42 indicates limited functional capacity and below. The aim of Study 2 is to investigate the efficacy and the neurophysiological effects of 2 types of tDCS protocols in facilitating upper limb motor recovery in patients with significant limitations in upper limb function.
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
- Single (Participant)
盲法说明
Participant in Group 1-3 will be blinded to the stimulation protocol that they will be receiving.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for stroke patients:
- •21-80 years old;
- •First ever stroke less than 6 weeks;
- •Moderate to severe upper limb impairment with Manual Muscle Testing (MMT) score on shoulder abduction plus finger extension (SAFE) <5 within the first week post-stroke.
- •Inclusion criteria for healthy subjects:
- •Age 21-80 years old;
- •No known medical history.
排除标准
- •for stroke patients:
- •Any metal implants inside the body that are contraindications of MRI scan;
- •cardiac pacemakers;
- •History of epilepsy;
- •Sensorimotor disturbance due to other causes other than stroke;
- •Claustrophobia;
- •Uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
- •Major depression and a history of psychotic disorders;
- •Terminal diagnosis with life expectancy <=1 year.
- •Exclusion criteria for healthy subjects:
- •Any metal implants inside the body that are contraindications of MRI scan;
- •cardiac pacemakers;
- •Claustrophobia.
研究组 & 干预措施
Anodal tDCS stimulation to the ipsilesional M1
Participant will receive 1 mA anodal tDCS stimulation to the ipsilesional M1 of cortical representation of the affected upper limb.
Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
干预措施: trancranial magnetic stimulation (Device)
Anodal tDCS to the contralesional premotor cortex
Participant will receive 1mA anodal tDCS to the contralesional premotor cortex. Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
干预措施: trancranial magnetic stimulation (Device)
Sham tDCS
Participant will receive sham tDCS stimulation with anode placed over the scalp area corresponding to ipsilesional M1.
Cathode will be used as reference electrode and placed over the supraorbital area contralateral to the anode. tDCS stimulation will be conducted daily for 20 sessions in consecutive days in the 4th month after stroke, with each session lasting for 20 minutes and combined with online occupational therapy training.
干预措施: trancranial magnetic stimulation (Device)
Control group
Subjects who fulfill the inclusion criteria of Study 2 but refuse tDCS stimulation.
结局指标
主要结局
Change of muscle spasticity using Modified Ashworth scale for spasticity (MAS)
时间窗: Change of muscle spasticity within 4 weeks, at 3 months, 6 months and 1 year after stroke onset
Upper limb function, 6 point scale, Scores range from 0 to 4 (namely 0, 1, 1+, 2, 3 and 4), where lower scores represent normal muscle tone and higher scores represent spasticity or increased resistance to passive movement.
Change of neural excitability using electroencephalogram (EEG)
时间窗: Change of the neural excitability within 4 weeks, at 3 months, 6 months and 1 year after stroke onset
High density EEG (electroencephalogram) evaluation of the electrical activity of the brain
Change of cortical excitability using Transcranial Magnetic Stimulation (TMS)
时间窗: Change of the cortical excitability within 4 weeks, at 3 months, 6 months and 1 year after stroke onset
measures of cortical excitability for those without TMS contraindications
Change of the upper extremity motor function using Fugl-Meyer scale
时间窗: Change of the upper extremity motor function within 4 weeks, at 3 months, 6 months and 1 year after stroke onset
Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.
Change of upper extremity performance (coordination, dexterity and functioning) using Action Research Arm Test
时间窗: Change of upper extremity performance within 4 weeks, at 3 months, 6 months and 1 year after stroke onset
Upper limb function, Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.
Change of neural excitability using Magnetic resonance imaging (MRI) scan
时间窗: Change of the neural excitability within 4 weeks, at 3 months, 6 months after stroke onset
Participants will go through one of the following image acquisition procedures 1) a functional MRI scans for brain activity together with motor task. 2) a 3D MPRAGE sequence for brain structure. 3) an advanced multishell high-resolution diffusion MRI for characterizing brain microstructure and extracellular space. 4) a FLAIR scan to measure white matter hyperintensity. Both functional and anatomical image acquisition will be undertaken using but not limited to gradient echo EPI sequence or its modified version.
次要结局
- Change of cognitive function using cognitive test(Change of cognitive function within 4 weeks, at 3 months, 6 months and 1 year after stroke onset)