in the present study, we examine the effect of tDCS and conventional occupational therapy on the quantitative changes in brain waves of schizophrenic patients and their cognitive functions.
Design
A randomized, single blinded (patients), sham controlled clinical trial with a parallel group design of 30 patients.
Settings and conduct
This study was carried out at Razi Psychiatric Hospital and in the occupational therapy room. control group receives electrical stimulation only in the first 30 seconds of intervention, and then the current is disconnected. Individuals will not be aware of their group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The diagnosis of schizophrenia by a psychiatrist, the Mini-Mental State Examination (MMSE) score higher than 17 for women and over 18 for men.
Exclusion criteria: paranoid type of schizophrenia, changes in drug regimen over the past month or during the intervention, patients with ECT history, patients with skin problems, patients with chronic neurological diseases or musculoskeletal disorder in the upper limb.
Intervention groups
The intervention will be 6 sessions that takes 20 minutes.
The anode electrode is placed on the F3 region, and the cathode electrode on the supraorbital area on the opposite side. An electrical stimulation with a 2 mA direct current will be applied to the F3 area. Patients in both groups will perform visual memory tasks during the intervention. The control group will receive only the first 30 seconds of electrical stimulation and they will do 3 visual memory tasks.
The first task is to remember the order of the cards, then find the cards that their places have changed. The second task is to memorize the cards and then name the deleted cards, and the third task is to remember the cards and then name them all perfectly.
Main outcome variables
Activity of different parts of the brain; Cognitive functions.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180317039116N1
Registration date:2018-05-10, 1397/02/20
Registration timing:registered_while_recruiting
Last update:2018-05-10, 1397/02/20
Update count:0
Registration date
2018-05-10, 1397/02/20
Registrant information
Name
Elahe Fathi Azar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3386 1366
Email address
el.fathiazar@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-17, 1397/01/28
Expected recruitment end date
2018-05-18, 1397/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of tDCS with conventional occupational Therapy in Improving cognitive functions in Patients with schizophrenia.
Public title
effects of tDCS on cognitive functions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of schizophrenia by a psychiatrist.
At least one year of being hospitalized.
Having MMSE score higher than 17 for ladies and 18 for men.
Exclusion criteria:
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
by using a coin.
Blinding (investigator's opinion)
Single blinded
Blinding description
To eliminate the difference in the sense of initiating electrical stimulation between the groups, the control group will only receive electrical stimulation in the first 30 seconds.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of University of Social Welfare and Rehabilitation Sciences
Street address
Department of Occupational Therapy, The University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjo Blvd, Evin, Tehran, Iran
City
tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2017-10-29, 1396/08/07
Ethics committee reference number
IR.USWR.REC.1396.404
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Cognitive Functions
Timepoint
Before and after intervention
Method of measurement
The Cambridge Neuropsychological Test Automated Battery (CANTAB)- The Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
Secondary outcomes
1
Description
brain activity
Timepoint
before and after intervention
Method of measurement
quantitative electroencephalography
Intervention groups
1
Description
Intervention group: In this study, tDCS device will be used to stimulate cortex. The intervention will consist of 6 sessions, each lasting for 20 minutes. The anode electrode will be placed on F3 region, the left DLPFC, based on an international system of 10-20 EEGs, and the cathode electrode will be placed on the supraorbital area on the opposite side. An electrical stimulation of 2 mAh through the surface of anodic electrode impregnated with a physiologic serum solution, will be applied on F3 cortex. The stimulation was delivered every other day, and all patients perform visual memory tasks during the stimulation. At each session, all participants spend 20 minutes on 3 Tasks of visual memory while receiving brain stimulation.The first task is to remember the order of the cards, then find the cards that their places has changed. The second task is to memorize the cards and then name the deleted cards, and the third task is to remember the cards and then name them all perfectly.
Category
Treatment - Devices
2
Description
Control group: In this study, tDCS device will be used to stimulate cortex. The intervention will consist of 6 sessions, each lasting for 20 minutes. The anode electrode will be placed on F3 region, the left DLPFC, based on an international system of 10-20 EEGs, and the cathode electrode will be placed on the supraorbital area on the opposite side. At the beginning of the sessions, an electrical stimulation with 2 mAh current would be applied to the F3 cortex for 30 seconds. Patients will not be informed about the interruption of the stimulation.The stimulation was delivered every other day. At each session, all participants spend 20 minutes on 3 Tasks of visual memory while receiving sham stimulation.The first task is to remember the order of the cards, then find the cards that their places have changed. The second task is to memorize the cards and then name the deleted cards, and the third task is to remember the cards and then name them all perfectly.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Elahe fathi azar
Street address
shahid rastegar blv, taghi abad conjunction, shahre rey, tehran
City
shahre rey
Province
Tehran
Postal code
18664
Phone
+98 21 3340 1226
Email
razi@uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
hojat allah haghgoo
Street address
Department of Occupational Therapy, The University of Social Welfare and Rehabilitation Sciences, Kodakyar St, Daneshjo Blvd, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Email
h.haghgoo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences