Stroke Clinical Trial
Official title:
The Comparative Effects of Dual-tDCS and Anodal Premotor tDCS Over the Contralesional Hemisphere on the Upper Limb Function and Manual Dexterity in Patients With Chronic Stroke: Single-blinded Randomized Controlled Trial
NCT number | NCT05180929 |
Other study ID # | IAU |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 10, 2017 |
Est. completion date | March 14, 2020 |
Verified date | December 2021 |
Source | Imam Abdulrahman Al Faisal Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Transcranial direct current stimulation (tDCS) has been gaining increasing interest as a potential therapeutic tool to improve upper extremity (UE) rehabilitation outcomes following stroke. Within the concept of interhemispheric inhibition (IHI), most tDCS studies have applied anodal ipsilesional and/or cathodal contralesional primary motor cortex (M1) tDCS to rebalance IHI and enhance motor recovery. However, compelling evidence suggests that an excitation/inhibition model is oversimplified, and the role of both hemispheres in the encoding of information during motor learning should be acknowledged. Moreover, multiple lines of evidence have demonstrated the potential relevance of contralesional premotor cortex (PMC) for recovery after M1 injury. Objective: We are aiming to investigate and compare the effects of two tDCS montages at different cortical sites (Dual-M1 vs. a-tDCS over contralesional PMC) by measuring the clinical outcomes of the most affected UE in patients with chronic subcortical stroke. Methods: 35 participants will be randomly assigned to 1 of 3 groups (Group A received dual- M1 tDCS, Group B received a-tDCS over contralesional PMC, and Group C received sham stimulation). tDCS will be applied using intensity of 2 mA for 20 min. (5 times/week) for 2 consecutive weeks. Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT) will be used to quantify the UE functional motor ability. Box and Block Test (BBT) will be used for gross manual dexterity and Nine Hole Peg Test (NHPT) will be used to measure fine hand dexterity. All measurements will be taken pre-treatment (T0) and post-treatment (T1) immediately after the 10th session, then 4 weeks after the end of stimulation period (T2) to assess the long-term effects. Expected results: This study would verify whether enhancing the motor cortical hyperexcitability in the contralesional hemisphere has a beneficial on recovery of the paretic hand, or regaining the balance of transcallosal inhibitory circuits between the motor areas in both hemispheres has more positive effects on the motor outcomes . This study would also provide a predictive approach to enable realistic rehabilitation goal-setting by identifying the proper tDCS montage for patients with stroke depending on their impairment level.
Status | Completed |
Enrollment | 35 |
Est. completion date | March 14, 2020 |
Est. primary completion date | March 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. First ever, unilateral, ischemic, subcortical stroke in the territories supplied by the Middle Cerebral Artery (MCA) verified by brain imaging, at chronic stage (= 6 months). 2. Upper Extremity impairment verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE) 3. Mini Mental State Examination Score = 24 Exclusion Criteria: 1. History of epileptic seizures. 2. Pre-stroke motor impairment(s) affecting UE. 3. Presence of UE contractures or deformities. 4. Botulinum toxin to UE muscles in the last 6 months. 5. Presence of damaged skin on the scalp that would interfere with tDCS stimulation. 6. Individuals with metallic implant in the brain or medical devices (i.e., cardiac pacemaker, deep brain stimulator, cochlear implants). 7. Use of CNS-affecting drugs. 8. Additional neurological or psychiatric problem. 9. Pregnancy. |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | BrainStim Lab, Imam Abdulrahman Bin Faisal University | Dammam | Eastern |
Lead Sponsor | Collaborator |
---|---|
Turki Abualait |
Saudi Arabia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline 'Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)' at 4 weeks | the most frequently used outcome measure when assessing UE function after stroke within the research context (Santisteban et al., 2016). We will exclude the 3 reflex items because they make no difference to the overall scores of the test (Gladstone, Danells and Black, 2002; Woodbury et al., 2007; Woytowicz et al., 2017). It is composed of 30 items, each scored on a scale of 0 to 2. It has an excellent overall reliability (Duncan, Propst and Nelson, 1983; Sanford et al., 1993), validity and responsiveness as an indicator of motor impairment severity across different stroke recovery time points (Platz et al., 2005; Hsieh et al., 2009). | T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects | |
Secondary | Change from Baseline 'Action Research Arm Test (ARAT)' at 4 weeks | is a standardized, observational measure of UE functional capability for adult stroke survivors. It includes 19 items categorized into four subscales (grasp, grip, pinch and gross movement). Task performance on each item is rated on a 4-point ordinal scale, ranging from 0 (no movement) to 3 (movement performed normally) (Yozbatiran, Der-Yeghiaian and Cramer, 2008). | T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects | |
Secondary | Change from Baseline 'Box and Block Test (BBT)' at 4 weeks | to assess gross manual dexterity. It consists of a wooden box divided by a partition into two equal compartments with 150 wooden blocks placed in one compartment. The participants will be given 60 seconds to move, one by one, as many 2.5 cm blocks as possible from one compartment to the other using only the most affected hand. 15-second trial will be allowed for each participant at the beginning to ensure adequate understanding of the task. BBT has excellent test-retest reliability when tested on more affected (r = 0.98) and less affected hand (r = 0.93) (Chen et al., 2009). | T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects | |
Secondary | Change from Baseline 'Nine Hole Peg Test (NHPT)' at 4 weeks | is a finger dexterity measure involving timed performance to insert and remove 9 pegs from holes in a wooden board. It showed excellent test retest reliability (Chen et al., 2009), adequate to excellent intra-rater reliability and excellent inter-rater reliability (Heller et al., 1987). | T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects |
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