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Status unknownNCT02506075Updated Jul 22, 2015

A Study of tDCS for Unilateral Neglect in Stroke Patients

An interventional study of Transcranical direct current stimulator and Visual inattention training in Stroke, sponsored by Pusan National University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-07-22.

Sponsored by Pusan National University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the 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.

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Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 105 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Pusan National University is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
105 participants (estimated)

Study arms

  • Experimental
    Pre-tDCS group

    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 · Behavioral: Visual inattention training

  • Experimental
    Simultaneous tDCS group

    In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously.

    Device: Transcranical direct current stimulator · Behavioral: Visual inattention training

  • No intervention
    Sham control group

    without transcranical direct current stimulator(tDCS) or without visual training

Interventions

  • DeviceTranscranical direct current stimulator

    approved by Conformity European as safe treatment device for stroke patients

  • BehavioralVisual inattention training
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What researchers measure

Primary outcomes

  1. Behavioral Inattention Test

    Line bisection test

    Time frame: up to 2 min

  2. Behavioral Inattention Test

    Letter cancellation test

    Time frame: up to 2 min

Secondary outcomes

  1. Behavioral Inattention Test

    Line bisection test

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

  2. Behavioral Inattention Test

    Letter cancellation test

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

  3. ADL assssement

    Catherine Bergego Scale

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

07

Study locations

1 of 1 sites recruiting
  • Pusan National University Yangsan Hospital
    Yangsan, 626-770, Korea, Republic of
    Recruiting
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References and documents

Publications

  • Adkins-Muir DL, Jones TA. Cortical electrical stimulation combined with rehabilitative training: enhanced functional recovery and dendritic plasticity following focal cortical ischemia in rats. Neurol Res. 2003 Dec;25(8):780-8. doi: 10.1179/016164103771953853. PubMed 14669519 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02506075
Lead sponsor
Pusan National University
Collaborators
Medwill hospital
Responsible party
Yong-il Shin (Associate Professor, Pusan National University) — Principal investigator
First posted
Jul 22, 2015
Start date
Apr 2015
Primary completion
Feb 2016 (estimated)
Completion
Feb 2016 (estimated)
Last update
Jul 22, 2015

Study contacts

Yong-Il Shin, Ph.D.
Contact
rmshin@gmail.com
82-55-360-2872
Yong-Il Shin
principal investigator · Pusan National University Yangsan Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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