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OpenTrials
Completed

NCT Number: NCT03486769

Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients

The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through three conditions of transcranial direct current stimulation with for 30 minutes. Three conditions are 1) Dual stimulation 1: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. 2) Dual stimulation 2: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. 3) Single stimulation: anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex.

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Key information

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • unilateral hemiplegic stroke patient
  • Fugl Meyer Assessment score between 9 to 84

Exclusion criteria

  • difficult to understand experimental tasks because of extremely severe cognitive impairment
  • history of psychiatric disease

Treatment and study plan

M1 stimulation

Device

stimulating primary motor cortex with anodal transcranial direct current stimulation

Other names: primary motor cortex anodal stimulation

PMC stimulation

Device

stimulating premotor cortex with anodal transcranial direct current stimulation

Other names: premotor cortex anodal stimulation

aIPS stimulation

Device

stimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation

Hand motor task

Behavioral

hand motor task for 30 minutes during transcranial direct current stimulation

Primary outcomes

  1. Changes in motor evoked potentia

    Time frame: Baseline and after intervention (approximately 2 weeks)

    measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.

Secondary outcomes

  1. changes in nine hole peg test

    Time frame: Baseline and after intervention (approximately 2 weeks)

    Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.

  2. changes in grip and tip pinch strength test

    Time frame: Baseline and after intervention (approximately 2 weeks)

    measure the hand strength (grip and tip pinch)

  3. changes in box and block test

    Time frame: Baseline and after intervention (approximately 2 weeks)

    box and block test measures unilateral gross manual dexterity

  4. Changes in brain activation of resting-state functional MRI

    Time frame: Baseline and after intervention (approximately 2 weeks)

    Neuroplasticity measure

  5. Changes of Cortical activation

    Time frame: Baseline and after intervention (approximately 2 weeks)

    Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany)

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Stroke Patients

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2018
Registry last updated
May 27, 2020

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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