A Study of tDCS for Unilateral Neglect in Stroke Patients

Study Overview
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Brief Summary
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The primary objective of this study is to confirm and compare the effect of methods of transcranial direct current stimulation(tDCS) in the unilateral neglect of stroke patients

Detailed Description
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Total 105 patients were recruited and randomized to receive either real or sham-tDCS. Real experimental groups were divided into two types; Pre-tDCS group and Simultaneous tDCS group. Two groups are again divided into three groups; Dual stimulation group, Unilateral stimulation group and Sham control group, respectively. In Pre-tDCS group, total a sessions of the tDCS stimulation was done for each three subgroups and visual inattention training was followed after that. In Simultaneous tDCS group, tDCS and visual inattention training was done simultaneously. For each subgroups, tDCS was attached at following locations; unilateral cathodal tDCS on unaffected PPC(postparietal cortex), P3 , dual cathodal tDCS on P3 and anodal tDCS on affected PPC, P4. The patients were initially evaluated at baseline, immediately, 60min, 120min, 24 hrs after the training session.

Official Title
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Effectiveness of Transcranial Direct Current Stimulation for Unilateral Neglect After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Transcranical direct current stimulator
* Behavioral: Visual inattention training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects who have diagnosed as primary stroke by physician's physical exam or radiologic diagnosis Subjects who have cortical or subcortical brain lesion Subjects ages older than 18years old Subjects who have 19 of K-MMSE score Subjects who has unilateral neglect with BIT-C less than 129 Subjects who understand the purpose of the study and acquired the consent of the patient or caregiver Subjects who had no effect from brain stimulation or electrical stimulation therapy Subjects whose dominant side are confirm by Edinburgh Handedness Inventory Exclusion criteria Subjects who have pre-existing and active major neurological disease Subjects who have pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia Subjects who have brain lesion except cortex or subcortex area Subjects who have any metal component after brain surgery, low threshold to pain, history of seizure Subjects who is estimated as not appropriate for the study by the investigators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-tDCS group<br>In Pre-tDCS group, total sessions of the transcranical direct current stimulator stimulation(tDCS) was done for each three subgroups and visual inattention training was followed after that. Patient had 2 times of tDCS for 13 minutes with 20minutes of resting interval. After that, additional 2 times of Visual inattention training was done with same protocol. | Device: Transcranical direct current stimulator<br>* approved by Conformity European as safe treatment device for stroke patients<br>Behavioral: Visual inattention training<br> <br> |
| Experimental: Simultaneous tDCS group<br>In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously. | Device: Transcranical direct current stimulator<br>* approved by Conformity European as safe treatment device for stroke patients<br>Behavioral: Visual inattention training<br> <br> |
| No Intervention: Sham control group<br>without transcranical direct current stimulator(tDCS) or without visual training | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Inattention Test | Line bisection test | up to 2 min | 
| Behavioral Inattention Test | Letter cancellation test | up to 2 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral Inattention Test | Line bisection test | 60 min, 120 min, 24 hrs after intervention | 
| Behavioral Inattention Test | Letter cancellation test | 60 min, 120 min, 24 hrs after intervention | 
| ADL assssement | Catherine Bergego Scale | 60 min, 120 min, 24 hrs after intervention |