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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486769
• Other study ID #: 2017-08-124-A
• Status: Completed
• Phase: N/A
• Start date: May 23, 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 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.

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 to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• M1 stimulation
stimulating primary motor cortex with anodal transcranial direct current stimulation
• PMC stimulation
stimulating premotor cortex with anodal transcranial direct current stimulation
• aIPS stimulation
stimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation

Behavioral:
• hand motor task
hand motor task 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 motor evoked potentia	measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.	Baseline and after intervention (approximately 2 weeks)
Secondary	changes in nine hole peg test	Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.	Baseline and after intervention (approximately 2 weeks)
Secondary	changes in grip and tip pinch strength test	measure the hand strength (grip and tip pinch)	Baseline and after intervention (approximately 2 weeks)
Secondary	changes in box and block test	box and block test measures unilateral gross manual dexterity	Baseline and after intervention (approximately 2 weeks)
Secondary	Changes in brain activation of resting-state functional MRI	Neuroplasticity measure	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)