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Dual Site-dual Channel Non-invasive Brain Stimulation for Language and Cognitive Function in Stroke Patients

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ClinicalTrials.gov Identifier: NCT03486782
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Aphasia Cognitive Impairment Device: IFG stimulation Device: DLPFC stimulation Behavioral: aphasia therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Language and Cognitive Function in Stroke Patients
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : March 17, 2020
Actual Study Completion Date : March 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dual stimulation
i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area ii) anodal stimulation on ipsilesional dorsolateral prefrontal cortex and cathodal stimulation of contralesional supraorbital area
 Device: IFG stimulation
stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes

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

Behavioral: aphasia therapy
aphasia therapy for 30 minutes during transcranial direct current stimulation
Active Comparator: Single stimulation 1
i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex
 Device: IFG stimulation
stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes

Behavioral: aphasia therapy
aphasia therapy for 30 minutes during transcranial direct current stimulation
Active Comparator: Single stimulation 2
i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area
 Device: IFG stimulation
stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes

Behavioral: aphasia therapy
aphasia therapy for 30 minutes during transcranial direct current stimulation


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486782


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
More Information
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03486782    
Other Study ID Numbers: 2017-08-124-B
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
transcranial direct current stimulation
dual stimulation
Additional relevant MeSH terms:
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Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations