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Completed

NCT Number: NCT04549753

A Study on Brain Activity During Transcranial Direct Current Stimulation in Stroke Patients

The purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current stimulation (tDCS) for the purpose of enhancing finger 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
  • Chronic patients over 6 months after onset
  • Subcortical stroke
  • 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 with metal implants
  • History of epilepsy
  • Pregnancy
  • Skin defect at the site of electrode attachment

Treatment and study plan

Transcranial direct current simulation

Device

Four sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system

Primary outcomes

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

    Time frame: Baseline and about 10 days (immediately after brain stimulation sessions)

    Cortical activities before and after brain stimulation sessions are compared.

Secondary outcomes

  1. Changes in motor evoked potential

    Time frame: Baseline and about 10 days (immediately after 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.

  2. 9-hole pegboard test

    Time frame: Baseline and about 10 days (immediately after 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 and about 10 days (immediately after 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 and about 10 days (immediately after 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 and about 10 days (immediately after 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. Finger tapping test

    Time frame: Baseline and about 10 days (immediately after brain stimulation sessions)

    Response time is measured during finger tapping task.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

A Study on Brain Activity During Transcranial Direct Current Stimulation for Improving Finger-Hand Function in Stroke Patients

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Mar 10, 2021

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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