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NCT Number: NCT04938076

Efficacy of Transcranial Direct Current Stimulation in Acute Ischemic Stroke

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Incheon, 21431, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Transcranial direct current stimulation on motor cortex

sham control

Device

sham control

Primary outcomes

  1. Fugl-Meyer (FM) motor scale, short form

    Time frame: at admission

    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).

  2. Fugl-Meyer (FM) motor scale, short form

    Time frame: at 7 days

    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).

  3. Fugl-Meyer (FM) motor scale, short form

    Time frame: at 3 month

    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).

  4. NIHSS (National Institutes of Health Stroke Scale)

    Time frame: at admission

    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).

  5. NIHSS (National Institutes of Health Stroke Scale)

    Time frame: at 7 days

    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).

  6. NIHSS (National Institutes of Health Stroke Scale)

    Time frame: at 3 month

    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).

Secondary outcomes

  1. modified Rankin scale

    Time frame: at 3 month

    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.

Sponsors and collaborators

Lead sponsor

Incheon St.Mary's Hospital

Other

Collaborators

  • The Catholic University of Korea

Registry information

Official study title

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

Acronym: DAS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2021
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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