A Study of tDCS for Unilateral Neglect in Stroke Patients

Pusan National University105 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

105

Conditions

Stroke

Interventions

Transcranical direct current stimulatorDEVICE

approved by Conformity European as safe treatment device for stroke patients

Visual inattention trainingBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

RECRUITING

Outcomes

Primary Outcomes

Behavioral Inattention Test

Line bisection test

Time frame: up to 2 min

Behavioral Inattention Test

Letter cancellation test

Time frame: up to 2 min

Secondary Outcomes

Behavioral Inattention Test

Line bisection test

Time frame: 60 min, 120 min, 24 hrs after intervention

Behavioral Inattention Test

Letter cancellation test

Time frame: 60 min, 120 min, 24 hrs after intervention

ADL assssement

Catherine Bergego Scale

Time frame: 60 min, 120 min, 24 hrs after intervention

Central Contacts

Yong-Il Shin, Ph.D.

CONTACT

82-55-360-2872 rmshin@gmail.com

Data from ClinicalTrials.gov

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