Neurophysiological and Behavioral Effects of Combining Transcranial Direct Current Stimulation (tDCS) and Modified-Constraint Induced Movement Therapy (mCIMT) on Upper Limb Function Recovery in Patients with Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Nine-Hole Peg Test (NHPT)
研究概览
简要总结
This clinical trial aims to evaluate the effect of different types of tDCS modulation with mCIMT in improving affected upper-limb motor function for stroke patients. The main question it seeks to answer:
Which type of tDCS (bi-hemispheric, anodal, or cathodal) combined with the mCIMT program leads to greater improvement in affected upper-limb function in patients with stroke? Researchers will compare these three types of tDCS to a sham tDCS. To see which kind of tDCS protocol combined with the mCIMT program will be more effective in improving affected upper-limb function for stroke patients.
Participants will:
- Participants will receive 12 sessions of mCIMT combined with tDCS or mCIMT alone.
- Visit the clinic three times a week for four weeks.
- Participants will do fMRI and TMS before and after the program and three times of assessment before and after two weeks after the program.
详细描述
Background: After a stroke, intense motor rehabilitation is required to facilitate motor recovery. In specific, combining tDCS with neurorehabilitation interventions boosts the responses of the brain to the interventions and maximizes the effects of rehabilitation to improve upper limb recovery post-stroke. Objectives: To evaluate the effect of different modes of tDCS modulation with mCIMT in improving affected upper-limb motor recovery for patients with stroke. Method: a randomizing control trial design, after performing a baseline assessment, the participants will be randomly assigned to one of the four groups: the anodal tDCS +mCIMT group, the cathodal tDCS +mCIMT group, the bihemispheric tDCS +mCIMT group, and the mCIMT alone group. Inclusion Criteria, adult participants clinically diagnosed and confirmed by imaging of ischemic or hemorrhagic cerebrovascular accident, participant's age older than 18 years, Stroke onset more than 3 months with unilateral motor deficits, Adequate cognitive function is required to follow instructions. The Arabic version of the Mini-Mental State Examination (MMSE) should be ≥24, 10° of active extension to the metacarpophalangeal and interphalangeal joints and 20° at the wrist, and not participating in other clinical, or research studies at the same time. Exclusion Criteria, Severe muscle spasticity at the affected limb at all joints (the Modified Ashworth Scale scores > 3), Contraindications to NIBS, unilateral neglect, Other neurologic or orthopedic conditions that may affect hand function, and unstable medical conditions. The total intervention period will be performed 3 times a week for 4 weeks. Each participant will undergo motor impairment and physiological assessments at baseline, during and after the intervention. Functional outcome measures: Fugl-Meyer Assessment Scale - upper extremity (FMA-UE), Wolf Motor Function Test (WMFT), Nine-Hole Peg Test (NHPT), Arabic version of Stroke Impact Scale (SIS-16), and Stroke-Specific Measure of Adherence to Home-based Exercises (SS-MAHE). Physiological outcome measures: Cortical Excitability Assessment will be measured by Transcranial Magnetic Stimulation (TMS) with electromyographic (EMG) and functional magnetic resonance imaging (fMRI).
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants clinically diagnosed and confirmed by imaging of ischemic or hemorrhagic cerebrovascular accident (Dahl et al., 2008; Jin et al., 2019).
- •Participant's age older than 18 years (Baltar et al., 2020).
- •Stroke onset more than 3 months with unilateral motor deficits (Lin et al., 2010).
- •Adequate cognitive function is required to follow instructions. The Arabic version of the Mini Mental State Examination (MMSE) should be ≥24 (Kim, 2021).
- •10° of active extension to the metacarpophalangeal and interphalangeal joints and 20° at wrist will be assessed by manual goniometer (Dahl et al., 2008).
- •Fugl-Meyer assessment (FMA) scores between 19 and 58, indicating moderate to mild impairments.
- •Not participating in other clinical, or research studies at the same time.
排除标准
- •Severe muscle spasticity at the affected limb at all joints (the Modified Ashworth Scale scores > 3) (Baltar et al., 2020).
- •Contraindications to NIBS (Bornheim et al., 2019).
- •Unilateral neglect (Dahl et al., 2008)
- •Other neurologic or orthopedic conditions that may affect hand function.
- •Unstable medical conditions.
研究组 & 干预措施
Anodal tDCS combined with mCIMT
20 minutes of anodal tDCS followed by 1 hour of the mCIMT program
干预措施: Anodal tDCS combined with mCIMT (Device)
Cathodal tDCS combined with mCIMT
20 minutes of cathodal tDCS followed by 1 hour of the mCIMT program
干预措施: Cathodal tDCS combined with mCIMT (Device)
Bihemispheric tDCS combined with mCIMT
20 minutes of bihemispheric tDCS followed by 1 hour of the mCIMT program
干预措施: Bihemispheric tDCS combined with mCIMT (Device)
Sham tDCS combined with mCIMT
20 minutes of anodal tDCS (after 30 seconds of stimulation, the stimulator will switch off) followed by 1 hour of the mCIMT program
干预措施: Sham tDCS combined with mCIMT (Device)
结局指标
主要结局
Nine-Hole Peg Test (NHPT)
时间窗: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
The Nine-Hole Peg Test (NHPT) is one of the most commonly used performance tests for measuring hand function and manual dexterity in stroke patients (Chen et al., 2009; Mathiowetz et al., 1985). The NHPT consists of a container with nine pegs and a pegboard with nine holes. The board will be placed at the midline of the patient, with the container containing the pegs on the side of the hand being evaluated. The NHPT requires the patient to pick up the pegs from the container with the affected upper limb, transfer and insert them into the holes of the pegboard until it is full, and then return them to the container. Patients will be instructed to complete the test as quickly and accurately as possible (Sommerfeld et al., 2004). The score will be based on the time it takes to complete the test activity, which will be recorded in seconds. The stopwatch should be started when the patient touches the first peg until the last peg is put in the container (Oxford Grice et al., 2003).
Cortical Excitability Assessment
时间窗: at baseline and after intervention ( 4 weeks).
The Transcranial Magnetic Stimulation (TMS) will be used to assess the corticospinal excitability through the measurement of the TMS-elicited motor evoked potential (MEP) in both the lesioned and the nonlesioned motor cortices (Wassermann et al., 2008). Online monitoring of the electromyographic (EMG) activity in response to TMS will be performed, MEPs will be recorded from the left and the right first interosseous (FDI) muscles
Fugl-Meyer Assessment Scale - upper extremity (FMA-UE)
时间窗: at baseline, and after 2 weeks, and after intervention (4 weeks).
The upper extremity domain of FMA consists of 33 items (reflex activity, volitional movement within synergies, volitional movement mixing synergies, volitional movement with little or no synergy, wrist, hand, coordination/ speed). On a 3-point ordinal scale, 0 = cannot perform, 1 = performs partially, and 2 = performs fully. The upper extremity domain has a total score of 66. A higher score indicated better performance of the affected side.
Wolf Motor Function Test (WMFT)
时间窗: at baseline and after intervention ( 4 weeks).
It is used to assess upper-limb performance through timed and functional tasks (Wolf et al., 2001). The WMFT is preferred to frequently used upper limb performance tests since it assesses a wide range of functional activities (from simple to complex) and investigates both performance time and movement quality (Morris et al., 2001). The modified WMFT consists of 17 items, 2 of which are strength measurements, and the remaining 15 items are functional tasks that gradually progress from simple movements in the proximal joint to complex movements in the distal joint. Each of the 15 tasks is timed to completion, up to a maximum of 120 seconds (Wolf et al., 2001). The items are scored on a 6-point scale ranging from 0 (does not attempt with the upper limb being tested) to 5 (uses the limb being tested, movement appears normal) (Wolf et al., 2005). A lower score indicates a lower functional level (Wolf et al., 2005).
Functional magnetic resonance imaging (fMRI)
时间窗: at baseline and after intervention ( 4 weeks).
Functional magnetic resonance imaging (fMRI) is a type of magnetic resonance imaging (MRI) that measures brain activity and connectivity. During an fMRI scan, a block design will be used. Each scan will take 6 minutes and be split into six blocks in the following order, with a rest of 30 seconds between each of the 15 contractions that last 2 seconds each and 30 seconds of rest in between (Wen et al., 2014). In each task, participants will be asked to grip a rubber ball at a target pressure of 30% of their maximum voluntary contraction using their affected hand (Cheng et al., 2021; Ismail et al., 2014). Visual feedback will be provided for the patients to guide the movement (Könönen et al., 2012).
Wolf Motor Function Test (WMFT)
时间窗: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
It is used to assess upper-limb performance through timed and functional tasks (Wolf et al., 2001). The WMFT is preferred to frequently used upper limb performance tests since it assesses a wide range of functional activities (from simple to complex) and investigates both performance time and movement quality (Morris et al., 2001). The modified WMFT consists of 17 items, 2 of which are strength measurements, and the remaining 15 items are functional tasks that gradually progress from simple movements in the proximal joint to complex movements in the distal joint. Each of the 15 tasks is timed to completion, up to a maximum of 120 seconds (Wolf et al., 2001). The items are scored on a 6-point scale ranging from 0 (does not attempt with the upper limb being tested) to 5 (uses the limb being tested, movement appears normal) (Wolf et al., 2005). A lower score indicates a lower functional level (Wolf et al., 2005).
次要结局
- Arabic version of Stroke Impact Scale (SIS-16)(at baseline, and after 2 weeks, and after intervention ( 4 weeks).)
- Motor Activity log (MAL)(at baseline, week 1, week 2, week 3 and after intervention ( 4 weeks).)
研究者
Dr. Alaa Albishi
Associate Professor
King Saud University
