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

Primary Purpose

Stroke, Aphasia, Cognitive Impairment

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

IFG stimulation

DLPFC stimulation

aphasia therapy

About this trial

This is an interventional treatment trial for Stroke focused on measuring transcranial direct current stimulation, dual stimulation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Dual stimulation

Single stimulation 1

Single stimulation 2

Arm Description

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

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area

Outcomes

Primary Outcome Measures

Changes in Korean Boston naming test

measures naming ability thorough picture naming test

Changes in Korean Western Aphasia Battery

assessment of language function and provide aphasia quotients

Secondary Outcome Measures

Digit span test

measures memory span

Korea Montreal Cognitive Assessment

measure cognitive function

Korean Color Word Stroop test

measures selective attention and executive function

Controlled Oral Word Association Test

measure verbal fluency

Changes of Cortical activation

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

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

Neuroplasticity measure

Full Information

NCT ID

NCT03486782

First Posted

March 22, 2018

Last Updated

May 25, 2020

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03486782

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

May 29, 2018 (Actual)

Primary Completion Date

March 17, 2020 (Actual)

Study Completion Date

March 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Aphasia, Cognitive Impairment

Keywords

transcranial direct current stimulation, dual stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dual stimulation

Arm Type

Active Comparator

Arm Description

Arm Title

Single stimulation 1

Arm Type

Active Comparator

Arm Description

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional inferior frontal cortex

Arm Title

Single stimulation 2

Arm Type

Active Comparator

Arm Description

i) anodal stimulation of ipsilesional inferior frontal cortex and cathodal stimulation of contralesional supraorbital area

Intervention Type

Device

Intervention Name(s)

IFG stimulation

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

DLPFC stimulation

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

aphasia therapy

Intervention Description

aphasia therapy for 30 minutes during transcranial direct current stimulation

Primary Outcome Measure Information:

Title

Changes in Korean Boston naming test

Description

measures naming ability thorough picture naming test

Time Frame

Baseline and after intervention (approximately 2 weeks)

Title

Changes in Korean Western Aphasia Battery

Description

assessment of language function and provide aphasia quotients

Time Frame

Baseline and after intervention (approximately 2 weeks)

Secondary Outcome Measure Information:

Title

Digit span test

Description

measures memory span

Time Frame

Baseline and after intervention (approximately 2 weeks)

Title

Korea Montreal Cognitive Assessment

Description

measure cognitive function

Time Frame

Baseline and after intervention (approximately 2 weeks)

Title

Korean Color Word Stroop test

Description

measures selective attention and executive function

Time Frame

Baseline and after intervention (approximately 2 weeks)

Title

Controlled Oral Word Association Test

Description

measure verbal fluency

Time Frame

Baseline and after intervention (approximately 2 weeks)

Title

Changes of Cortical activation

Description

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

Time Frame

Baseline and after intervention (approximately 2 weeks)

Title

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

Description

Neuroplasticity measure

Time Frame

Baseline and after intervention (approximately 2 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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