Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT03486769
• Lead Sponsor: Samsung Medical Center

Brief Summary

The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor 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 three conditions of transcranial direct current stimulation with for 30 minutes. Three conditions are 1) Dual stimulation 1: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. 2) Dual stimulation 2: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. 3) Single stimulation: anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-04-01
• Study First Posted: 2018-04-03
• Study Start: 2018-05-23
• Status Verified: 2020-03
• Primary Completion: 2020-03-17
• Study Completion: 2020-03-17
• Last Update Submitted: 2020-05-25
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• unilateral hemiplegic stroke patient
• Fugl Meyer Assessment score between 9 to 84

Exclusion Criteria

• difficult to understand experimental tasks because of extremely severe cognitive impairment
• history of psychiatric disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in motor evoked potentia	Baseline and after intervention (approximately 2 weeks)	measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.

Secondary Outcome Measures

Name	Time	Method
changes in grip and tip pinch strength test	Baseline and after intervention (approximately 2 weeks)	measure the hand strength (grip and tip pinch)
Changes in brain activation of resting-state functional MRI	Baseline and after intervention (approximately 2 weeks)	Neuroplasticity measure
changes in nine hole peg test	Baseline and after intervention (approximately 2 weeks)	Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.
Changes of Cortical activation	Baseline and after intervention (approximately 2 weeks)	Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany)
changes in box and block test	Baseline and after intervention (approximately 2 weeks)	box and block test measures unilateral gross manual dexterity

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of