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Completed

NCT Number: NCT04903457

The Effect of tDCS on Motor Learning and Neural Network in Stroke Patients

This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation on motor learning to stroke patients compared to 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 including basal ganglia lesion patients
  • Chronic patients over 6 months after onset
  • 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.

Motor learning

Behavioral

Sequential finger tapping task training is applied to stroke patients.

Primary outcomes

  1. Fugl-Meyer Assessment

    Time frame: Baseline, 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.

Secondary outcomes

  1. Changes in cortical activity using fNIRS signals during brain stimulation

    Time frame: Baseline, during, immediately after five brain stimulation sessions

    Cortical activities before, during and after brain stimulation sessions are compared.

  2. Changes in motor evoked potential

    Time frame: Baseline, immediately after five brain stimulation sessions

    Resting motor threshold (rMT) and amplitude of motor evoked potential in 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.

  3. 9-hole pegboard test

    Time frame: Baseline, immediately after five brain stimulation sessions

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

  4. Grip & Tip pinch strength test

    Time frame: Baseline, immediately after five brain stimulation sessions

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

  5. Box & Block test

    Time frame: Baseline, 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.

  6. Sequential Finger tapping test

    Time frame: Baseline, immediately after five brain stimulation sessions

    Response time is measured during sequential finger tapping task.

  7. Jebsen-Taylor hand function test

    Time frame: Baseline, 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).

Other outcomes

  1. Resting-state functional MRI

    Time frame: Baseline (Before stimulation sessions)

    Before intervention, MRI is acquired to extract brain characteristics of stroke patients.

  2. Changes in cortical activity using fNIRS signals.

    Time frame: Baseline (Before stimulation sessions)

    Before intervention, fNIRS image is acquired to extract cortical activation of stroke patients.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Investigation of Compensational Mechanism and Effect of Transcranial Direct Stimulation on Motor Learning Through Neural Network Analysis in Stroke Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 26, 2021
Registry last updated
Mar 1, 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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