A Study of tDCS for Unilateral Neglect in Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Transcranical direct current stimulator Device
    Intervention Desc: approved by Conformity European as safe treatment device for stroke patients
    ARM 1: Kind: Experimental
    Label: Pre-tDCS group
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Simultaneous tDCS group
    Description: In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously.
  • Visual inattention training Behavioral
    ARM 1: Kind: Experimental
    Label: Pre-tDCS group
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Simultaneous tDCS group
    Description: In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Behavioral Inattention Test up to 2 min No
Secondary ADL assssement 60 min, 120 min, 24 hrs after intervention No

Sponsors