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Completed

NCT Number: NCT05142917

The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients

The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.

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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 aged 19 to 80 years
  • Patients with subacute stroke within 4 weeks of onset
  • Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation

Exclusion criteria

  • Accompanied by an existing serious neurogenic disease
  • Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia.
  • If there are difficulties in conducting the research
  • Any patients who are judged by the investigator to be difficult to participate in this study
  • Exclusion criteria for transcranial direct current stimulation:

i) Patients with implanted medical devices in the body (e.g. pacemakers) ii) When a metal object is inserted in the skull iii) If there is a wound on the skin of the attachment site iv) history of epilepsy v) Pregnant and lactating women

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.

Hand motor task

Behavioral

Various type of hand motor tasks are applied to stroke patients.

Primary outcomes

  1. Changes of score: Fugl-Meyer Assessment

    Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session

    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 of score: 9-hole pegboard test

    Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session

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

  2. Changes of score: Grip & Tip pinch strength test

    Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session

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

  3. Changes in Box & Block test

    Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session

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

  4. Changes of score: Jebsen-Taylor hand function test

    Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session

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

  5. Changes of score: Korean-Montreal Cognitive Assessment

    Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session

    This test is a cognitive function test tool consisting of spatiotemporal/executive function, naming, memory, attention, language function, abstraction, and orientation.

  6. Changes of score: Korean version of Modified Barthel Index

    Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session

    Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions.

  7. Changes of score: Geriatric Depression Scale-Short Form

    Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session

    The test is a self-report measure of depression in older adults.

  8. Changes in cortical activity using fNIRS signals

    Time frame: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session

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

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 3, 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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