Back to resultsA Study of tDCS for Unilateral Neglect in Stroke Patients
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transcranical direct current stimulator
Visual inattention training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility 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
Sites / Locations
- Pusan National University Yangsan HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Pre-tDCS group
Simultaneous tDCS group
Sham control group
Arm 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.
In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously.
without transcranical direct current stimulator(tDCS) or without visual training
Outcomes
Primary Outcome Measures
Behavioral Inattention Test
Line bisection test
Behavioral Inattention Test
Letter cancellation test
Secondary Outcome Measures
Behavioral Inattention Test
Line bisection test
Behavioral Inattention Test
Letter cancellation test
ADL assssement
Catherine Bergego Scale
Full Information
NCT ID
NCT02506075
First Posted
July 21, 2015
Last Updated
July 21, 2015
Sponsor
Pusan National University
Collaborators
Medwill hospital
1. Study Identification
Unique Protocol Identification Number
NCT02506075
Brief Title
A Study of tDCS for Unilateral Neglect in Stroke Patients
Official Title
Effectiveness of Transcranial Direct Current Stimulation for Unilateral Neglect After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University
Collaborators
Medwill hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-tDCS group
Arm Type
Experimental
Arm 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 Title
Simultaneous tDCS group
Arm Type
Experimental
Arm Description
In Simultaneous transcranical direct current stimulator(tDCS) group, tDCS and visual inattention training was done simultaneously.
Arm Title
Sham control group
Arm Type
No Intervention
Arm Description
without transcranical direct current stimulator(tDCS) or without visual training
Intervention Type
Device
Intervention Name(s)
Transcranical direct current stimulator
Intervention Description
approved by Conformity European as safe treatment device for stroke patients
Intervention Type
Behavioral
Intervention Name(s)
Visual inattention training
Primary Outcome Measure Information:
Title
Behavioral Inattention Test
Description
Line bisection test
Time Frame
up to 2 min
Title
Behavioral Inattention Test
Description
Letter cancellation test
Time Frame
up to 2 min
Secondary Outcome Measure Information:
Title
Behavioral Inattention Test
Description
Line bisection test
Time Frame
60 min, 120 min, 24 hrs after intervention
Title
Behavioral Inattention Test
Description
Letter cancellation test
Time Frame
60 min, 120 min, 24 hrs after intervention
Title
ADL assssement
Description
Catherine Bergego Scale
Time Frame
60 min, 120 min, 24 hrs after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-Il Shin, Ph.D.
Phone
82-55-360-2872
Email
rmshin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Il Shin
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
ZIP/Postal Code
626-770
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong-Il Shin, Ph.D.
Phone
82-55-360-2872
Email
rmshin01@gmail.com
First Name & Middle Initial & Last Name & Degree
Min Su Park, MS
Phone
82-55-360-4154
Email
minsu.park.otr@gmail.com
First Name & Middle Initial & Last Name & Degree
Yong-Il Shin, Ph.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
14669519
Citation
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.
Results Reference
background
Learn more about this trial
A Study of tDCS for Unilateral Neglect in Stroke Patients
We'll reach out to this number within 24 hrs