Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke

Study Overview
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Brief Summary
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Non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe in participants with cerebral infarction. However, few studies have been done in participants with acute cerebral infarction. In this study, the investigators want to see the effect of tDCS in acute cerebral infarction. the investigators perform tDCS in participants with acute ischemic stroke within 48 hours after stroke onset and the investigators measure motor weakness and function at early phase as well as at 3 months.

Detailed Description
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Cerebral infarction is a major cause of death, a disease that is socially and nationally burdensome, leaving disabilities and dementia behind. In participants with cerebral infarction, non-invasive brain stimulation (tDCS) such as transcranial direct current stimulation (TDCS) has been reported to be effective in improving motor performance and safe. However, few studies have been done in participants with acute cerebral infarction, and previous studies in participants with acute cerebral infarction have not verified the effect in mild cerebral infarction, and previous studies in acute cerebral infarction mainly stimulate lesions to anode. So in this study, the investigators want to see the effect of stimulating tDCS to both hemispheres in acute cerebral infarction against this backdrop. Study Objective: To see if tDCS is effective in improving motor paralysis in participants with acute cerebral infarction. Expected effectiveness: stability of tDCS has already been demonstrated in many studies. Since tDCS itself is a non-invasive treatment, if the efficacy of the tDCS prove to be effective in patients with acute cerebral infarction, it can be widely implemented without significant risk to many patients. Intervention : In this randomized controlled trial, the investigators perform tDCS in patients with acute ischemic stroke within 48 hours after stroke onset with sham control. Outcome : the investigators measure motor weakness and function at early phase as well as at 3 months.

Official Title
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Investigation of the Effects of Noninvasive Neuromodulation in Patients With Acute Ischemic Infarction

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic stroke patients within 2 days stroke onset 18-85 of age corticospinal tract involvement stroke (primary motor cortex, corona radiata, internal capsule, midbrain crus cerebri, basis pontis, anterior medulla) Exclusion Criteria: pre-stroke disability (defined as modified Rankin Scale (mRS) >=2) Intravenous r-tPA thrombolysis or EVT (endovascular thrombectomy) history of epilepsy advanced systemic disease or coexisting neurological/psychiatric disease severe contact dermatitis or skin lesions interfering with the applying the electrode of tDCS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded randomized control trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS group<br>tDCS stimulation affected side : primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2mA anode (+) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days) contralateral unaffected side primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2mA cathode (-) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days) | Device: Transcranial direct current stimulation<br>* Transcranial direct current stimulation on motor cortex<br>|
| Sham Comparator: Sham group<br>. Sham stimulation 1) the current ramps up to 2mA and slowly decreased over 30 s to ensure the typical initial tingling sensation | Device: Transcranial direct current stimulation<br>* Transcranial direct current stimulation on motor cortex<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer (FM) motor scale, short form | The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit). | at admission | 
| Fugl-Meyer (FM) motor scale, short form | The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit). | at 7 days | 
| Fugl-Meyer (FM) motor scale, short form | The Fugl-Meyer motor scale (FM) is widely used in clinical trials to quantify motor deficits after stroke. FM short form consists 12 items ranging from 0 (worst motor deficit) to 24 (no motor deficit). | at 3 month | 
| NIHSS (National Institutes of Health Stroke Scale) | National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit). | at admission | 
| NIHSS (National Institutes of Health Stroke Scale) | National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit). | at 7 days | 
| NIHSS (National Institutes of Health Stroke Scale) | National Institutes of Health Stroke Scale (NIHSS) as a Neurologic. Assessment Tool in Stroke Patients ranging from 0 (no neurologic deficit) to 42 (severe neurologic deficit). | at 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin scale | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials. | at 3 month |