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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03486782
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 21.6
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Aphasia; Cognitive Impairment	Device: IFG stimulation; Device: DLPFC stimulation; Behavioral: aphasia therapy	N/A

Study Design

• Study Type: Interventional
• 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: Mar 17, 2020
• Actual Study Completion Date: Mar 17, 2020

Arms and Interventions

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

Primary Outcome Measures

1. Changes in Korean Boston naming test [Baseline and after intervention (approximately 2 weeks)]

   measures naming ability thorough picture naming test

2. Changes in Korean Western Aphasia Battery [Baseline and after intervention (approximately 2 weeks)]

   assessment of language function and provide aphasia quotients

Secondary Outcome Measures

1. Digit span test [Baseline and after intervention (approximately 2 weeks)]

   measures memory span

2. Korea Montreal Cognitive Assessment [Baseline and after intervention (approximately 2 weeks)]

   measure cognitive function

3. Korean Color Word Stroop test [Baseline and after intervention (approximately 2 weeks)]

   measures selective attention and executive function

4. Controlled Oral Word Association Test [Baseline and after intervention (approximately 2 weeks)]

   measure verbal fluency

5. Changes of Cortical activation [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 [Baseline and after intervention (approximately 2 weeks)]

   Neuroplasticity measure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03486782
• Other Study ID Numbers: 2017-08-124-B
• First Posted: Apr 3, 2018
• Last Update Posted: May 27, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Stroke; Aphasia

Study Results

No Results Posted as of May 27, 2020