Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation - a Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Upper Extremity Component of Fugl-Meyer Assessment
研究概览
简要总结
Stroke is the most common cause of adult disability. Current treatments for functional loss of the upper extremity post-stroke remain limited in efficacy, particularly for those with moderate to severe impairment.
Previous studies have demonstrated the efficacy of transcranial direct current stimulation (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is effective to enhance motor recovery, with activation of neural pathways similar to that of motor execution. This treatment is accessible to more severely impaired stroke survivors. Our previous studies have demonstrated feasibility and efficacy of motor imagery-based brain computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is detected by surface EEG and translated to execution of the target movement with the aid of an arm robot (MIT-Manus).
In this study, we investigate the feasibility of combining robot-assisted MI-BCI training, with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI. Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic stimulation (TMS).
We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI) vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each session. Primary outcome will be functional ability measured by upper extremity component of the Fugl-Meyer Assessment. Secondary outcome measures will be the Box & Block Test, Modified Ashworth Score (measuring spasticity), grip strength and measures of brain activity including transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging (MRI) measures including functional MRI and diffusion tensor imaging (DTI).
This study will be important to develop a new and effective treatment (tDCS-BCI) for post-stroke motor impairment.
详细描述
This is a randomised controlled trial of 32 subjects who have sustained their first ever subcortical stroke more than 9 months prior to study enrollment, with upper extremity impairment of 11-45 out of a maximum score of 66 on the Fugl-Meyer assessment scale.
Subjects will be randomly allocated to one of the following 2 groups by using a computer-generated random sequence:
- 10 sessions over 2 weeks of MI-BCI training with 20 minutes of tDCS preceding training.
- 10 sessions over 2 weeks of MI-BCI training with 20 minutes of sham-tDCS preceding training.
tDCS-BCI protocol Each of the 10 sessions of tDCS-BCI or sham-BCI will be conducted as follows: tDCS will be performed for 20 minutes immediately prior to each session of motor training. The anode will be placed over the M1 motor cortex of the affected hemisphere while the cathode will be placed over the unaffected M1.
After initial calibration, MI-BCI training will involve MI of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time and will be undertaken by a research assistant blinded to the condition of tDCS.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first ever haemorrhagic or ischaemic subcortical stroke more than 9 months prior to study enrollment
- •upper extremity impairment of 11-45 on the Fugl-Meyer assessment scale
排除标准
- •cognitive impairment
- •other neurological or psychiatric diseases
- •severe arm pain
- •spasticity score >2 on the Modified Ashworth Scale in the shoulder or elbow
- •contraindications to TMS or tDCS (cranial implants, ventricular shunts, pacemakers, intrathecal pumps)
- •grip strength <10kg as measured by a dynamometer
- •participation in other interventions or trials targeting stroke motor recovery.
结局指标
主要结局
Upper Extremity Component of Fugl-Meyer Assessment
时间窗: week 0, week 2, week 4
The total FMA score (range, 0-66) on the stroke-impaired upper extremity was used to measure the motor improvements in this study. Higher score indicates better upper limb motor function. FMA were measured at 3 time points: at baseline (wk 0), at completion of intervention (wk 2), and at a 2-week follow-up (wk 4).
次要结局
- Resting Motor Threshold of Stroke Affected M1 Motor Cortex(pre- and post-training, 4 weeks post-training)
- Grip Strength(pre- and post-training, and again at 4 weeks post-training)
- Box and Block Test(pre and post training, and 4 weeks post training)
- MRI Parameters(-2, 0 and 4 weeks)