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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486782
• Other study ID #: 2017-08-124-B
• Status: Completed
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: March 17, 2020

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Cognitive Dysfunction
• Cognitive Impairment
• Stroke

Intervention

Device:
• IFG stimulation
stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes
• 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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Korean Boston naming test	measures naming ability thorough picture naming test	Baseline and after intervention (approximately 2 weeks)
Primary	Changes in Korean Western Aphasia Battery	assessment of language function and provide aphasia quotients	Baseline and after intervention (approximately 2 weeks)
Secondary	Digit span test	measures memory span	Baseline and after intervention (approximately 2 weeks)
Secondary	Korea Montreal Cognitive Assessment	measure cognitive function	Baseline and after intervention (approximately 2 weeks)
Secondary	Korean Color Word Stroop test	measures selective attention and executive function	Baseline and after intervention (approximately 2 weeks)
Secondary	Controlled Oral Word Association Test	measure verbal fluency	Baseline and after intervention (approximately 2 weeks)
Secondary	Changes of Cortical activation	Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany)	Baseline and after intervention (approximately 2 weeks)
Secondary	Changes in brain activation of resting-state and task functional MRI	Neuroplasticity measure	Baseline and after intervention (approximately 2 weeks)