Clinical trial NCT04938076: Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke
Official title: Investigation of the Effects of Noninvasive Neuromodulation in Patients With Acute Ischemic Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of Korea
First posted: 2021-06-24
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded randomized control trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fugl-Meyer (FM) motor scale, short form
timeFrame: at admission
measure: Fugl-Meyer (FM) motor scale, short form
timeFrame: at 7 days
measure: Fugl-Meyer (FM) motor scale, short form
timeFrame: at 3 month
measure: NIHSS (National Institutes of Health Stroke Scale)
timeFrame: at admission
measure: NIHSS (National Institutes of Health Stroke Scale)
timeFrame: at 7 days
measure: NIHSS (National Institutes of Health Stroke Scale)
timeFrame: at 3 month
Secondary outcomes:
measure: modified Rankin scale
timeFrame: at 3 month
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
Study officials:
affiliation: Incheon St.Mary's Hospital
name: Taewon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: