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Completed

NCT Number: NCT05275114

Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function

The purpose of this study was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and 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

  • Patients aged 19 to 80 years
  • Less than 58 FMA Upper scores
  • Patients whose lesions do not include stimulation regions
  • Patients with stroke with more than 3 months of onset

Exclusion criteria

  • Difficult to communicate due to severe language impairment.
  • Accompanied by an existing serious neurogenic disease
  • Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder
  • If there are difficulties in conducting the research
  • Any patients who are judged by the investigator to be difficult to participate in this study
  • Patients with contraindicated MRI scans

Treatment and study plan

tDCS stimulation with hand task

Device

30 minutes of intervention including tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks

sham tDCS stimulation with hand task

Device

30 minutes of intervention including sham tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks

Primary outcomes

  1. Change in Fugl-Meyer Assessment

    Time frame: Session 0 (initial visit);; Session 10 (at approximatel 4 weeks)

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

Secondary outcomes

  1. Change in 9-hole pegboard test

    Time frame: Baseline(initial visit); Session 10 (at approximatel 4 weeks)

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

  2. Change in Grip & Tip pinch strength

    Time frame: Baseline(initial visit); Session 10 (at approximatel 4 weeks)

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

  3. Change in Sequential finger tapping reaction time and accruacy

    Time frame: Baseline(initial visit); Session 10 (at approximatel 4 weeks)

    Response time and accuracy are measured during finger tapping task.

  4. Change in Jebsen-Taylor hand function test

    Time frame: Baseline(initial visit); Session 10 (at approximatel 4 weeks)

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

  5. Change in Box and Block test

    Time frame: Baseline(initial visit); Session 10 (at approximatel 4 weeks)

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

  6. Changes in motor evoked potential

    Time frame: [Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]

    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.

  7. Changes in Brain activation of resting-state functional MRI

    Time frame: [Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)]

    Measure of Neuroplasticity

Sponsors and collaborators

Lead sponsor

Yun-Hee Kim

Other

Collaborators

  • Cybermedic Co., Ltd.

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2022
Registry last updated
Sep 21, 2022

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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