Effectiveness Cognitive rehabilitation therapy (CRT) And Transcranial Direct Current Stimulation (TDCS) In people with spatial neglect
Design
Clinical trial, double blind, randomized, with two groups.
Settings and conduct
A sample will be conducted of hospitals affiliated to Iran University of Medical Sciences.Interventions will be done in the brain and cognition clinic of the cognitive neuroscience research institute.
Participants/Inclusion and exclusion criteria
stroke diagnoised by Neurologist and MRI ,No aphasia and associated neurological disorders (Parkinson's, MS, ALS, Alzheimer's disease),First stroke, 25 - 80 years old, At least 9 successful grades education,Middle cerebral attract with spatial neglect symptom, 1-12 months post stroke
Intervention groups
first group in 10 session both cognitive rehabilitation training and TDCS for 45 minute
second group 10 session cognitive rehabilitation training and sham for 45 minute
Main outcome variables
improving visual attention function
General information
Reason for update
Acronym
CRT - TDCS
IRCT registration information
IRCT registration number:IRCT20120910010806N7
Registration date:2018-12-25, 1397/10/04
Registration timing:retrospective
Last update:2018-12-25, 1397/10/04
Update count:0
Registration date
2018-12-25, 1397/10/04
Registrant information
Name
Malahat Akbarfahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
akbarfahimi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness Cognitive rehabilitation therapy (CRT) And Transcranial Direct Current Stimulation (TDCS) In people with spatial neglect
Public title
Effectiveness Cognitive rehabilitation therapy (CRT) And Transcranial Direct Current Stimulation (TDCS) In people with spatial neglect
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
stroke diagnoised by Neurologist and MRI
No aphasia and associated neurological disorders (Parkinson's, MS, ALS, Alzheimer's disease)
First stroke
25 - 80 years old
At least 9 successful grades education
Middle cerebral attract with spatial neglect symptom
1-12 months post stroke
Exclusion criteria:
Not attending over 2 session cognitive treatment
Age
From 25 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
6
Randomization (investigator's opinion)
Randomized
Randomization description
Review the records of in patients and outpatients stroke patients who referred to the department of the neurology of hospitals of Iran University of Medical Sciences between 1 to 12 months ago , allocated the eligible patients into 2 groups by simple randomization using digits table by a blind person to the aim of the study
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants will be unaware of the group they are entering.This means that after randomization by the therapist, the patient does not know which treatment method will be used for him Because only the remedy is mentioned in the satisfaction and there are no explanations for the two therapies.After completing the treatment, the data will be entered in SPSS and statistically analysis by blind person to the 2 treatment groups.
Placebo
Used
Assignment
Parallel
Other design features
one of the groups get both cognitive training exercises and trans cranial current stimulation. and the other group get cognitive training exercises and sham intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-08-04, 1397/05/13
Ethics committee reference number
IR.IUMS.REC.1397.152
Health conditions studied
1
Description of health condition studied
Cerebral Vascular Accident
ICD-10 code
G46.0
ICD-10 code description
Middle cerebral artery syndrome
Primary outcomes
1
Description
improving function of visual attention
Timepoint
assessment in every 2 session
Method of measurement
star cancellation . line bisection . eye tracker device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: TDCS and Cognitive rehabilitation training. Group of intervention: first group of TDCS and cognitive rehabilitation. group 2: applying cognitive rehabilitation to the right hemisphere and the right hemisphere in this group, in addition to applying restoration computer tasks and saccadic training in addition to 10 sessions and each session for 20 min (at the same time with restoration training)with intensity of 2 ms, were applied while performing computer cognitive tasks. anode electrode was applied to the P4 area and catode electrode in area P.
Category
Rehabilitation
2
Description
Intervention group: cognitive rehabilitation training and sham. Group 2: using the cognitive rehabilitation of computer tasks associated with the اعمال of the right hemisphere and the left side of the left hemisphereThe intervention in this group, in addition to carrying out restoration computer assignments and saccadic training, were applied three times per week for 10 minutes and each session for 20 min (at the same time with restoration training), while applying computer cognitive tasks. anode electrode was applied to the P4 area and catode electrode in area P.