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A Study of tDCS for Unilateral Neglect in Stroke Patients

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ClinicalTrials.gov Identifier: NCT02506075
Recruitment Status : Unknown
Verified July 2015 by Yong-il Shin, Pusan National University.
Recruitment status was:  Recruiting
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
Sponsor:
Collaborator:
Medwill hospital
Information provided by (Responsible Party):
Yong-il Shin, 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

Condition or disease Intervention/treatment Phase
Stroke Device: Transcranical direct current stimulator Behavioral: Visual inattention training Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Transcranial Direct Current Stimulation for Unilateral Neglect After Stroke
Study Start Date : April 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Arm Intervention/treatment
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
approved by Conformity European as safe treatment device for stroke patients

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
approved by Conformity European as safe treatment device for stroke patients

Behavioral: Visual inattention training
No Intervention: Sham control group
without transcranical direct current stimulator(tDCS) or without visual training



Primary Outcome Measures :
  1. Behavioral Inattention Test [ Time Frame: up to 2 min ]
    Line bisection test

  2. Behavioral Inattention Test [ Time Frame: up to 2 min ]
    Letter cancellation test


Secondary Outcome Measures :
  1. Behavioral Inattention Test [ Time Frame: 60 min, 120 min, 24 hrs after intervention ]
    Line bisection test

  2. Behavioral Inattention Test [ Time Frame: 60 min, 120 min, 24 hrs after intervention ]
    Letter cancellation test

  3. ADL assssement [ Time Frame: 60 min, 120 min, 24 hrs after intervention ]
    Catherine Bergego Scale



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506075


Contacts
Contact: Yong-Il Shin, Ph.D. 82-55-360-2872 rmshin@gmail.com

Locations
Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of, 626-770
Contact: Yong-Il Shin, Ph.D.    82-55-360-2872    rmshin01@gmail.com   
Contact: Min Su Park, MS    82-55-360-4154    minsu.park.otr@gmail.com   
Principal Investigator: Yong-Il Shin, Ph.D.         
Sponsors and Collaborators
Pusan National University
Medwill hospital
Investigators
Principal Investigator: Yong-Il Shin Pusan National University Yangsan Hospital

Publications:
Responsible Party: Yong-il Shin, Associate Professor, Pusan National University
ClinicalTrials.gov Identifier: NCT02506075     History of Changes
Other Study ID Numbers: PNUYH-03-2015-005
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases