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| Name | Class |
|---|---|
| King Saud Medical City | OTHER_GOV |
| King Fahad Medical City | OTHER_GOV |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS combined with mCIMT | Experimental | 20 minutes of anodal tDCS followed by 1 hour of the mCIMT program |
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| Cathodal tDCS combined with mCIMT | Experimental | 20 minutes of cathodal tDCS followed by 1 hour of the mCIMT program |
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| Bihemispheric tDCS combined with mCIMT | Experimental | 20 minutes of bihemispheric tDCS followed by 1 hour of the mCIMT program |
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| Sham tDCS combined with mCIMT | Sham Comparator | 20 minutes of anodal tDCS (after 30 seconds of stimulation, the stimulator will switch off) followed by 1 hour of the mCIMT program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anodal tDCS combined with mCIMT | Device | 20 minutes of anodal tDCS followed by 1 hour of the mCIMT program. The anodal electrode will be placed over the ipsilesional M1 (primary motor cortex, C3 or C4 according to EEG 10/20 system), and the cathodal electrode over the contralateral supraorbital area (Fp1 or Fp2) ). Leading to subthreshold depolarization to promote cortical excitation. And twelve different oriented tasks will be used during the 1-hour training period. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment Scale - upper extremity (FMA-UE) | 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. | at baseline, and after 2 weeks, and after intervention (4 weeks). |
| Wolf Motor Function Test (WMFT) | 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). | at baseline, and after 2 weeks, and after intervention ( 4 weeks). |
| Nine-Hole Peg Test (NHPT) | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Arabic version of Stroke Impact Scale (SIS-16) | Stroke Impact Scale (SIS-16) is a stroke specific, self-reported outcome measure used to assess the impact of stroke on health-related quality of life status related to physical function (P. Duncan et al., 2003). It consists of 16 items, basic and instrumental activities of daily living (7 items), mobility (8 items), and hand function (1 item) on a 5-level Likert scale, 1 = inability to complete the item; 5 = not difficult at all (P. Duncan et al., 2003; P. W. Duncan et al., 2003). Higher scores indicate a better level of health-related quality of life status for stroke patients (P. W. Duncan et al., 2003). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaa M. Albishi, PhD in Rehabilitation Sciences | Contact | +966555090015 | aalbeshi@KSU.EDU.SA | |
| Ahmad O. Alokaily, PhD | Contact | +966557447442 | aalokaily@ksu.edu.sa |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Saud University Medical City | Recruiting | Riyadh | Riyadh Region | 12372 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33299400 | Background | Baltar A, Piscitelli D, Marques D, Shirahige L, Monte-Silva K. Baseline Motor Impairment Predicts Transcranial Direct Current Stimulation Combined with Physical Therapy-Induced Improvement in Individuals with Chronic Stroke. Neural Plast. 2020 Nov 25;2020:8859394. doi: 10.1155/2020/8859394. eCollection 2020. |
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| Cathodal tDCS combined with mCIMT | Device | 20 minutes of cathodal tDCS followed by 1 hour of the mCIMT program. the cathodal electrode will be placed over the contralesional M1, and the anodal electrode over the contralateral supraorbital area (Fp1 or Fp2). leading to subthreshold polarization to promote cortical inhibition. And twelve different oriented tasks will be used during the 1-hour training period. |
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| Bihemispheric tDCS combined with mCIMT | Device | 20 minutes of Bihemispheric tDCS followed by 1 hour of the mCIMT program. the cathodal electrode will be placed over the primary motor cortex (M1) of the contralesional hemisphere and the anodal electrode will be placed above the ipsilateral M1 position (C3 or C4 positions, according to the 10/20 EEG system). And twelve different oriented tasks will be used during the 1-hour training period. |
|
| Sham tDCS combined with mCIMT | Device | 20 minutes of sham tDCS followed by 1 hour of the mCIMT program. the same stimulation place and parameters will be used as in the anodal group. However, after 30 seconds of stimulation, the stimulator will switch off. This provides the participants with the experience of the initial itchy sensation that occurs during tDCS, which is required for efficient masking. And twelve different oriented tasks will be used during the 1-hour training period. |
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| at baseline, and after 2 weeks, and after intervention ( 4 weeks). |
| Cortical Excitability Assessment | 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 | at baseline and after intervention ( 4 weeks). |
| Functional magnetic resonance imaging (fMRI) | 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). | at baseline and after intervention ( 4 weeks). |
| Wolf Motor Function Test (WMFT) | 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). | at baseline and after intervention ( 4 weeks). |
| at baseline, and after 2 weeks, and after intervention ( 4 weeks). |
| Motor Activity log (MAL) | The MAL consists of two scales; amount of use (AOU), which is the amount the stroke patient uses on the affected limb, and quality of movement (QOM), which is the patient's perceived quality of movement while performing 30 items of daily life (Taub et al., 1993). The items are scored on a 6-point scale ranging from 0 (did not use my weaker arm) to 5 (used my weaker arm as often as before the stroke) for measuring AOU; and to measure QOM, the patient is asked how well the affected limb helped during this activity. Possible scores range from 0 (my weaker arm was not used at all for that activity) to 5 (the ability to use my weaker arm for that activity was as good as before the stroke) (Taub et al., 1993). | at baseline, week 1, week 2, week 3 and after intervention ( 4 weeks). |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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