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

Study Overview
=================
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.

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

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: M1 stimulation
* Device: PMC stimulation
* Device: aIPS stimulation
* Behavioral: hand motor task


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual Stimulation 1<br>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. | Device: M1 stimulation<br>* stimulating primary motor cortex with anodal transcranial direct current stimulation<br>* Other names: primary motor cortex anodal stimulation;Device: PMC stimulation<br>* stimulating premotor cortex with anodal transcranial direct current stimulation<br>* Other names: premotor cortex anodal stimulation;Behavioral: hand motor task<br>* hand motor task for 30 minutes during transcranial direct current stimulation<br>|
| Experimental: Dual Stimulation 2<br>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. | Device: M1 stimulation<br>* stimulating primary motor cortex with anodal transcranial direct current stimulation<br>* Other names: primary motor cortex anodal stimulation;Device: aIPS stimulation<br>* stimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation<br>Behavioral: hand motor task<br>* hand motor task for 30 minutes during transcranial direct current stimulation<br>|
| Experimental: Single stimulation<br>anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex | Device: M1 stimulation<br>* stimulating primary motor cortex with anodal transcranial direct current stimulation<br>* Other names: primary motor cortex anodal stimulation;Behavioral: hand motor task<br>* hand motor task for 30 minutes during transcranial direct current stimulation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| changes in grip and tip pinch strength test | measure the hand strength (grip and tip pinch) | Baseline and after intervention (approximately 2 weeks) | 
| changes in box and block test | box and block test measures unilateral gross manual dexterity | Baseline and after intervention (approximately 2 weeks) | 
| Changes in brain activation of resting-state functional MRI | Neuroplasticity measure | Baseline and after intervention (approximately 2 weeks) | 
| Changes of Cortical activation | Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) | Baseline and after intervention (approximately 2 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcranial direct current stimulation, dual stimulation