Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke (DAS)

Investigation of the Effects of Noninvasive Neuromodulation in Patients With Acute Ischemic 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 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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Transcranial direct current stimulation

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 Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Taewon Kim, MD, PhD; Phone Number: +82-10-9399-5452; Email: kimtaewon79@gmail.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 21431
    • Recruiting
    • The Catholic University of Korea, Incheon St. Mary's Hospital
    • Contact: Taewon Kim, MD, PhD; Phone Number: +82-10-9399-5452; Email: kimtaewon79@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS group; 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 sideprimary 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; Transcranial direct current stimulation on motor cortex
Sham Comparator: Sham group; . 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; Transcranial direct current stimulation on motor cortex

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Incheon St.Mary's Hospital
• Collaborators: The Catholic University of Korea
• Investigators: Principal Investigator: Taewon Kim, MD, PhD, Incheon St.Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2020
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 20, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: OC19DESI0124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No