Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke

NCT ID: NCT04938076

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-16
• Study Completion Date: 2024-02-01

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

tDCS group

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)

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

Transcranial direct current stimulation on motor cortex

Sham group

. Sham stimulation

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

Group Type: SHAM_COMPARATOR

sham control

Intervention Type: DEVICE

sham control

Interventions

Transcranial direct current stimulation

Transcranial direct current stimulation on motor cortex

Intervention Type: DEVICE

sham control

sham control

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: collaborator

Incheon St.Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Taewon Kim

Assistant Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Taewon Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Incheon St.Mary's Hospital

Locations

The Catholic University of Korea, Incheon St. Mary's Hospital

Incheon, , South Korea

Countries

South Korea

Other Identifiers

OC19DESI0124

Identifier Type: -

Identifier Source: org_study_id