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Completed

NCT Number: NCT04699331

Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients

This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.

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Key information

Conditions

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

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Unilateral stroke patients
  • Chronic patients over 6 months after onset
  • Patients with motor evoked potential of the first dorsal interosseous muscle
  • Patients with the movement of fingers

Exclusion criteria

  • History of psychiatric disease
  • Significant other neurological diseases except for stroke
  • Difficult to perform this experiment
  • Patients who are deemed difficult to participate in this research by the investigator
  • Patients with metal implants and medical devices
  • History of epilepsy
  • Pregnancy
  • Skin defect at the site of electrode attachment

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.

Primary outcomes

  1. Changes in motor evoked potential

    Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

    Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response. The latency is defined as the time point from the onset of the stimulus to the onset of MEP.

Secondary outcomes

  1. Jebsen-Taylor hand function test

    Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

    This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).

  2. 9-hole peg test

    Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

    The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.

  3. Grip & Tip pinch strength test

    Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

    The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.

  4. Box & Block test

    Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

    The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.

  5. Fugl-Meyer Assessment

    Time frame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)

    The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.

  6. Sequential motor test

    Time frame: Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions)

    Response time and accuracy are measured during finger tapping task.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Pusan National University Yangsan Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2021
Registry last updated
Feb 3, 2023

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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