NCT03486782

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 29, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

May 27, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

March 22, 2018

Last Update Submit

May 25, 2020

Conditions

StrokeAphasiaCognitive Impairment

Keywords

transcranial direct current stimulationdual stimulation

Outcome Measures

Primary Outcomes (2)

  • Changes in Korean Boston naming test

    measures naming ability thorough picture naming test

    Baseline and after intervention (approximately 2 weeks)

  • Changes in Korean Western Aphasia Battery

    assessment of language function and provide aphasia quotients

    Baseline and after intervention (approximately 2 weeks)

Secondary Outcomes (6)

  • Digit span test

    Baseline and after intervention (approximately 2 weeks)

  • Korea Montreal Cognitive Assessment

    Baseline and after intervention (approximately 2 weeks)

  • Korean Color Word Stroop test

    Baseline and after intervention (approximately 2 weeks)

  • Controlled Oral Word Association Test

    Baseline and after intervention (approximately 2 weeks)

  • Changes of Cortical activation

    Baseline and after intervention (approximately 2 weeks)

  • +1 more secondary outcomes

Study Arms (3)

Dual stimulation

ACTIVE COMPARATOR

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 stimulationDevice: DLPFC stimulationBehavioral: aphasia therapy

Single stimulation 1

ACTIVE COMPARATOR

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

Device: IFG stimulationBehavioral: aphasia therapy

Single stimulation 2

ACTIVE COMPARATOR

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

Device: IFG stimulationBehavioral: aphasia therapy

Interventions

IFG stimulationDEVICE

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

Dual stimulationSingle stimulation 1Single stimulation 2
DLPFC stimulationDEVICE

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

Dual stimulation
aphasia therapyBEHAVIORAL

aphasia therapy for 30 minutes during transcranial direct current stimulation

Dual stimulationSingle stimulation 1Single stimulation 2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

StrokeAphasiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 3, 2018

Study Start

May 29, 2018

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

May 27, 2020

Record last verified: 2020-03

Locations

KR(1)