Efficacy of the Non-invasive Brain Stimulation Techniques for Lower Limb Recovery in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- changes of " gait parameters" from baseline to post-intervention and 4 weeks after intervention
研究概览
简要总结
This study is to compare the efficacy of two types of non-invasive brain stimulation (NIBS) in lower limb motor function recovery in stroke patients. The intervention will be tDCS (transcraniel direct current stimulation) or rTMS (repetitive transcraniel magnetic stimulation) plus conventional gait training for 10 days over 2 weeks.
The study hypothesizes that:
- When combined with conventional gait training, NIBS could improve the walking ability of stroke survivors.
- NIBS will modulate cortex activity of the brain area representing the lower limbs.
- The effects of NIBS might be related to some genetic factors. 45 subjects will be randomly divided into 3 groups, receiving tDCS plus conventional gait training, or rTMS plus conventional gait training, or sham tDCS plus conventional gait training.
The outcome measures include clinical functional assessment, brain activity assessed by TMS measurement and MRI, genetic factor measurement. All these will be done at pre, immediate after intervention and 4 weeks after intervention.
详细描述
This is an exploratory randomized trial on 45 subacute stroke subjects with gait impairment following a single anterior circulation subcortical stroke 3-6 months prior to recruitment, with comfortable walking speed of 0.2 to 0.4 m/s (which generally describes those who require 1 person assistance to supervision for ambulation - Functional Ambulatory Category (FAC) 3 (Kollen, et al. 2006). Exclusion criteria include a history of seizures, uncontrolled medical condition or psychiatric history, neglect, aphasia, or any cognitive or behavioural impairment causing inability to comply with instructions, cranial surgeries, pacemakers and other implants which preclude the use of NIBS. Subjects on psychoactive medications (eg. antiepileptics, antipsychotic and antidepressant medications) will be excluded from the study. The diagnosis for subjects' eligibility to join the study will be determined by subjects' self-report (to obtain medical history), medical records (to verify subjects' self-report) as well as assessment by the research staff in the screening session (including FMA and 10 meter walk test, ). Subjects should have completed inpatient rehabilitation and should not be undergoing any other interventions targeting lower limb recovery during the study. Subjects are allowed to continue with outpatient rehabilitation (generally not more than twice a week) and home exercise program after the active intervention phase of the study.
45 subjects with stroke will be recruited and randomized into 3 groups by a randomization stratification approach with a computer-generated random sequence. Group 1 to receive facilitatory 2 mA anodal tDCS for 20min to the affected M1 motor cortical representation of the tibialis anterior muscle (TA) together with conventional post-stroke functional mobility training; Group 2 to receive 2000 pulses of 10 Hz facilitatory rTMS to the affected motor cortex with conventional therapy; Group 3 to receive sham stimulation with conventional therapy. All groups will receive 2 weeks (10 days) of tDCS, rTMS or sham stimulation combined with daily standardized post-stroke conventional training in functional mobility.
tDCS A research staff supervised by a physician will apply the tDCS to the subject. Direct current will be transferred by a saline-soaked pair of surface sponge electrode (35cm2) and delivered by a battery-operated, constant current stimulator with a maximum output of 10mA, through a non-metallic conductor rubber electrode. Stimulation will be conducted at the intensity of 2 mA and last for 20 minutes. The anode will be placed over the affected primary motor cortex (M1) of cortical representation of the tibialis anterior muscle (TA), while the cathode will be used as reference electrode and placed over the forehead of the unaffected side.
Sham stimulation The same stimulation parameters as tDCS treatment will be employed for the sham stimulation. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception rTMS A research staff supervised by a physician will apply the intervention of rTMS to the subject. For all TMS procedures, patients will be seated comfortably and instructed to remain as still as they can. The height of the chair will be adjusted so that both the knees and ankles are flexed at 90 degree and the two feet rest on the floor. A tight swim cap will be worn by the subject. The vertex will be marked on the cap. Points that are 1 cm lateral and/or 1cm posterior/anterior are marked on the cap.
Subjects will receive 10 Hz rTMS using Magstim Rapid2, with the double cone coil placed over the "hot spot" of the affected M1. The stimulation intensity will set as 90% of RMT (or 80% AMT, if RMT is not available), and a total of 2000 pulses will be delivered for one treatment session.
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
- Single (Outcomes Assessor)
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
- •For subjects receiving intervention:
- •Male or female aged 21-80 years;
- •First ever haemorrhagic or ischaemic subcortical stroke of 3-6 months prior to study enrolment;
- •Functional Ambulatory Category 3 (requires not more than minimal assistance for walking);
- •Be able to provide informed consent.
- •For healthy subjects:
- •Male or female aged 21-80 years;
- •Physically healthy;
- •Be able to provide informed consent.
- •Exclusion criteria:
- •For subjects receiving intervention:
- •Severe claustrophobia;
- •cardiac pacemakers;
- •orthodontics (braces);
- •metal implant;
- •presence of other non MRI-compatible ferromagnetic implants;
- •history of epilepsy;
- •sensorimotor disturbance due to other causes other than stroke;
- •severe pain in the lower limbs affecting gait;
- •uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
- •major depression and a history of psychotic disorders (Subject with BDI score more than 30 will be excluded).
- •For healthy subjects:
- •Cardiovascular diseases;
- •Diabetes mellitus;
- •Pulmonary diseases;
排除标准
- 未提供
结局指标
主要结局
changes of " gait parameters" from baseline to post-intervention and 4 weeks after intervention
时间窗: before intervention, immediately after intervention, 4 weeks after intervention
Gait analysis will be performed using the Tekscan walkway system. Subjects will be required to walk on a mat at their comfort speed. Gait parameters including step and stride parameters, symmetry scores, velocity, and cadence temporal will be collected and recorded while the subject is walking along the walkway.
次要结局
- changes of walking speed measured by "10 meter walk test" from baseline to post-intervention and 4 weeks after intervention(before intervention, immediately after intervention, 4 weeks after intervention)
- changes of " Blood BDNF level" from baseline to post-intervention and 4 weeks after intervention(before intervention, immediately after intervention, 4 weeks after intervention)
- changes of " cortical excitability measured by fMRI" from baseline to post-intervention and 4 weeks after intervention(before intervention, immediately after intervention, 4 weeks after intervention)
- changes of "cortical excitability measured by TMS" from baseline to post-intervention and 4 weeks after intervention(before intervention, immediately after intervention, 4 weeks after intervention)
- changes of " Psychological and cognitive properties" from baseline to post-intervention and 4 weeks after intervention(before intervention, immediately after intervention, 4 weeks after intervention)
- changes of walking distance measured by "6 minute walk test " from baseline to post-intervention and 4 weeks after intervention(before intervention, immediately after intervention, 4 weeks after intervention)
- changes of " timed up-to-go test " from baseline to post-intervention and 4 weeks after intervention(before intervention, immediately after intervention, 4 weeks after intervention)