Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Ischemic Stroke

• Registration Number: NCT04938076
• Lead Sponsor: Incheon St.Mary's Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-04-16
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-20
• Study First Posted: 2021-06-24
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NIHSS (National Institutes of Health Stroke Scale)	at 3 month	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).
Fugl-Meyer (FM) motor scale, short form	at 3 month	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).

Secondary Outcome Measures

Name	Time	Method
modified Rankin scale	at 3 month	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.

Trial Locations

Locations (1)

The Catholic University of Korea, Incheon St. Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of