Augmenting the Effects of Mirror Therapy for Stroke Rehabilitation by tDCS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- EEG Physiological Assessments
研究概览
简要总结
This project is to evaluate and compare the impact of tDCS stimulation location on augmenting MT effects.
详细描述
Mirror therapy (MT) has emerged as an effective treatment approach for stroke rehabilitation. To augment the effects of MT, one appealing approach is to combine MT with transcranial direct current stimulation (tDCS) to promote neuroplasticity. However, it remains undetermined as to how tDCS may be effectively and efficiently applied in conjunction with MT. The long term goal of this project will be to identify the optimal combination approach of MT and tDCS to enhance recovery after stroke. The stimulation timing and location of tDCS in relation to MT will be varied, and the scientific evidence will be built upon by the evaluation of comprehensive outcome measures. This project will also investigate the possible electroencephalography (EEG) physiological and motor control mechanisms, and study predictors of treatment success to identify the appropriate patient population for the hybrid regimen.
Specifically, the first aim of this project is to evaluate and compare the impact of tDCS stimulation location on augmenting MT effects. The tDCS will be applied either before or concurrently with MT, and will be applied either over primary motor cortex (M1) or premotor cortex (PMC). Outcome measures will include behavioral performances selected based on the International Classification of Functioning, Disability and Health (ICF) framework, EEG physiological measures, and kinematic control of upper extremity (UE) movements. All the outcome measures will be assessed before and immediately after the intervention, and only behavioral performances will be evaluated at 3- and 6-month follow-up. Investigators hypothesize that immediately after intervention, the participants who receive MT combined with tDCS will demonstrate greater improvements in the outcomes than those who receive MT with sham tDCS. Investigators also hypothesize that the stimulation location of tDCS will induce differential therapeutic effects on the outcome measures.
The second aim of this study is to examine the retention performance of the behavioral outcomes at 3-and 6-month follow-up. Investigators hypothesize that the beneficial effects of the hybrid therapy will be retained 3 and 6 months post intervention.
The third aim of this study is to perform subsequent analysis of exploring whether patients with primary motor cortex involved will respond to various types of treatment differently from those without primary motor cortex involved.
The fourth aim of the study is to identify the characteristics of responders for the hybrid therapy. The possible predictors of post treatment changes in behavioral (the aspects of activities and participation), EEG physiological, and kinematic measures will be determined. Investigators hypothesize that the behavioral (the aspect of motor impairment), the EEG physiological and the kinematic measures will be good predictors for the treatment outcomes.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sustained an unilateral stroke with onset ≥ 6 months;
- •UE-FMA score between 18 and 56 indicating moderate to mild motor severity;
- •aged from 45 to 85 years old; and
- •able to follow instructions and perform the tasks (Mini Mental State Examination ≥ 24).
排除标准
- •have excessive spasticity or joint contracture of the paretic UE;
- •are enrolled in other rehabilitation experiments or drug studies;
- •have additional neurological or psychological disorders other than stroke;
- •have received Botulinum toxin injections 3 months before enrollment;
- •have unstable cardiovascular status such as uncontrolled hypertension or New York Heart Association (NYHA) Class III/IV heart failure;
- •have contradictions to tDCS including a history of epilepsy, migraine headache, uncontrolled medical status, being pregnant, having a pacemaker, or metal implanted in their head or body; and
- •have a history of drug or alcohol abuse, skin lesions on the electrode sites, brain tumor, brain injury, arteriovenous malformation (AVM), had brain surgery, other brain diseases (such as intracranial hypertension or cerebral edema), or being not suitable for using tDCS by the physician's assessment.
结局指标
主要结局
EEG Physiological Assessments
时间窗: baseline, posttest (1 month)
A wireless EEG device will be used to evaluate treatment-induced changes on cortical activity by ERD of mu rhythm EEG during the movements for reaching for pressing the desk button. The mu rhythm is a specific frequency range (8-12 Hz) in the EEG signal and the amplitude decrease in mu-rhythm power (called ERD) can be used to depict the temporal pattern of cortical activity when preparing, producing, and controlling movement events. The averaged area of the entire ERD curve under the reference level will be used as the amplitude parameter of cerebral activation. To characterize the ERD difference between the affected hemisphere and the unaffected hemisphere, a lateralization index (LI) will be used: LI = (ERDR- ERDL)/(ERDL+ERDR), where ERDR and ERDL represent the overall ERD areas (cerebral activation) of the C4 and C3 (or F4 and F3) channels. Significant increase of ERD in the damaged hemisphere and increase of LI will be indicators for a good recovery.
Kinematic Protocols
时间窗: baseline, posttest (1 month)
The movement of the markers will be captured with a 7-camera motion analysis system. The reaching movements will be recorded at a frequency of 120 Hz, and low-pass filtered at 5 Hz using a 2nd-order Butterworth filter with dual-passes. The kinematic variables for data analysis will include reaction time(RT), movement time(MT), peak velocity(PV), the percentage of MT where peak velocity occurs(PPV), movement units(MU), and maximum grip aperture(MGA). MGA is obtained only during the reach-to-grasp tasks. Less RT and MT suggest better movement efficiency, while higher amplitude of PPV indicates a more preplanned movement. A fewer number of MUs would suggest a smoother movement induced by the treatment. Larger MGA indicates a better, skilled strategy. Larger changes in the angles of shoulder, elbow, and wrist will indicate a better movement, while smaller angular changes and movement distance of the trunk will represent less trunk compensatory movement.
次要结局
- Change scores of Modified Ashworth Scale (MAS)(baseline, posttest (1 month))
- Change scores of Fugl-Meyer Assessment (FMA)(baseline, posttest (1 month), follow-up (up to 3 months), follow-up (up to 6 months))
- Change scores of Daily Living Self-Efficacy Scale (DLSES)(baseline, posttest (1 month))
- Functional Independence Measure (FIM)(baseline, posttest (1 month))
- Change scores of Wolf Motor Function Test (WMFT)(baseline, posttest (1 month))
- Change scores of The Chedoke Arm and Hand Activity Inventory (CAHAI)(baseline, posttest (1 month))
- Stroke Self-Efficacy Questionnaire (SSEQ)(baseline, posttest (1 month))
- Change scores of Functional Abilities Confidence Scale (FACS)(baseline, posttest (1 month))
- 10-Meter Walk Test (10MWT)(baseline, posttest (1 month))
- Commander Algometer(baseline, posttest (1 month))
- Change scores of Motor Activity Log (MAL)(baseline, posttest (1 month), follow-up (up to 3 months), follow-up (up to 6 months))
- The Pittsburgh Sleep Quality Index (PSQI)(baseline, posttest (1 month))
- Revised Nottingham Sensory Assessment (rNSA)(baseline, posttest (1 month))
- Medical Research Council scale (MRC)(baseline, posttest (1 month))
- Grip and Pinch Power(baseline, posttest (1 month))
- Nottingham Extended Activities of Daily Living Scale (NEADL)(baseline, posttest (1 month), follow-up (up to 3 months), follow-up (up to 6 months))
- Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0)(baseline, posttest (1 month), follow-up (up to 3 months), follow-up (up to 6 months))
- Dual-Task Block and Box Test(baseline, posttest (1 month), follow-up (up to 3 months), follow-up (up to 6 months))
- MyotonPro(baseline, posttest (1 month))
- Actigraphy(baseline, posttest (1 month))