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

Incheon St.Mary's Hospital

Status

Completed

Conditions

Ischemic Stroke

Treatments

Device: Transcranial direct current stimulation

Device: sham control

Study type

Interventional

Funder types

Other

Identifiers

NCT04938076

OC19DESI0124

Details and patient eligibility

About

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.

Full 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.

Enrollment

172 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

172 participants in 2 patient groups

tDCS group

Experimental group

Description:

tDCS stimulation * affected side : 1. primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2. 2mA anode (+) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days) * contralateral unaffected side 1. primary motor cortex (M1 cortex by using the C3 or C4 position of the 10-20 EEG system) 2. 2mA cathode (-) for 30 minutes total 10 times for 7 days (ex) twice a day for 5 days)

Treatment:

Device: Transcranial direct current stimulation

Sham group

Sham Comparator group

Description:

. Sham stimulation 1) the current ramps up to 2mA and slowly decreased over 30 s to ensure the typical initial tingling sensation

Treatment:

Device: sham control