Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke

Ischemic Stroke Clinical Trial

— DAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938076
• Other study ID #: OC19DESI0124
• Status: Recruiting
• Phase: Phase 3
• Start date: April 16, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2021
• Source: Incheon St.Mary's Hospital
• Contact: Taewon Kim, MD, PhD
• Phone: +82-10-9399-5452
• Email: kimtaewon79[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Transcranial direct current stimulation
Transcranial direct current stimulation on motor cortex

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Incheon St. Mary's Hospital	Incheon

Sponsors (2)

Lead Sponsor	Collaborator
Incheon St.Mary's Hospital	The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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