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Completed

NCT Number: NCT03486782

Dual Site-dual Channel Non-invasive Brain Stimulation for Language and Cognitive 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 language and cognitive 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 four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on ipsilesional inferior frontal cortex, ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex. 2) Single stimulation 1: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional inferior frontal cortex; 3) Single stimulation 2: anodal stimulation on ipsilesional inferior frontal cortex and cathodal stimulation on contralesional supraorbital area.

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Key information

Conditions

Stroke Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Communication Disorders Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Vascular Diseases

Age range

19 year and older

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

  • left hemisphere involved stroke patients
  • patients diagnoses as post stroke aphasia

Exclusion criteria

  • history of psychiatric disease
  • patients with metal implants
  • history of epilepsy
  • pregnancy
  • skin defect at the site of electrode attachment

Treatment and study plan

IFG stimulation

Device

stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes

DLPFC stimulation

Device

stimulating dorsolateral prefrontal cortex with transcranial direct current stimulation for 30 minutes

aphasia therapy

Behavioral

aphasia therapy for 30 minutes during transcranial direct current stimulation

Primary outcomes

  1. Changes in Korean Boston naming test

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

    measures naming ability thorough picture naming test

  2. Changes in Korean Western Aphasia Battery

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

    assessment of language function and provide aphasia quotients

Secondary outcomes

  1. Digit span test

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

    measures memory span

  2. Korea Montreal Cognitive Assessment

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

    measure cognitive function

  3. Korean Color Word Stroop test

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

    measures selective attention and executive function

  4. Controlled Oral Word Association Test

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

    measure verbal fluency

  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)

  6. Changes in brain activation of resting-state and task functional MRI

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

    Neuroplasticity measure

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 Language and Cognitive 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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