A Study of tDCS for Unilateral Neglect in Stroke Patients

Not Applicable

• Conditions: Stroke
• Interventions: Device: Transcranical direct current stimulator; Behavioral: Visual inattention training

• Registration Number: NCT02506075
• Lead Sponsor: Pusan National University

Brief Summary

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

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 Timeline

• Study Start: 2015-04
• Status Verified: 2015-07
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-21
• Last Update Submitted: 2015-07-21
• Study First Posted: 2015-07-22
• Last Update Posted: 2015-07-22
• Primary Completion: 2016-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-tDCS group	Transcranical direct current stimulator	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.
Simultaneous tDCS group	Transcranical direct current stimulator	In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously.
Pre-tDCS group	Visual inattention training	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.
Simultaneous tDCS group	Visual inattention training	In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously.

Primary Outcome Measures

Name	Time	Method
Behavioral Inattention Test	up to 2 min	Letter cancellation test

Secondary Outcome Measures

Name	Time	Method
ADL assssement	60 min, 120 min, 24 hrs after intervention	Catherine Bergego Scale
Behavioral Inattention Test	60 min, 120 min, 24 hrs after intervention	Letter cancellation test

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of