The potential effect of transcranial direct current stimulation(tDCS) as an add-on to main-stream cognitive treatment in subjective cognitive impairment referring to cognitive clinics in Shiraz (َA sham-control study )
1.Evaluation of cognitive function in Subjective Cognitive Impairment(SCI) subjects after receiving tDCS in the dorsolateral part of Pre Frontal Cortex (dlPFC) and Parietal Cortex (PC) 2. Evaluation of fMRI components including Functional Connectivity after receiving tDCS in the(dlPFC) and(PC) 3. Determining the correlation of fMRI findings with the outcome of cognitive functions of patients after receiving tDCS 4.Comparing the effectiveness of real-tDCS and Sham-tDCS in improving cognitive functions in SCI .
Design
A randomized, double blinded, sham controlled clinical trial with a parallel group design of 20 patients, we will use block method for randomization
Settings and conduct
The primary interview and basic cognitive tests are conducted in the neuroscience laboratory ,participants randomly enroll in to the one of two groups of study, and receive ten treatment sessions(real or sham tDCS +cognitive rehabilitation exercises).At the end, the cognitive tests of the first session will be repeated. Ten of these people will do MRI at the beginning and end of the sessions.
Participants/Inclusion and exclusion criteria
incl. criteria: People (male/female) who have complaints about their cognitive functions, In performing cognitive tests, impairment can be seen in at least two cognitive areas; age between 30- 65
ex. criteria: Presence of clinical diagnosis of any neuropsychological disorder in medical history; drug abuse; VAS(visual analog scale) scale > 5 ; Presence of sever attention and concentration disorder; chronic sleep disorder ; using drugs with memory disturbances side effects; sever anxiety; history of head trauma; history of brain surgery; epilepsy
Improving the cognitive status of SCI patients, especially in memory domain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181109041598N2
Registration date:2022-11-15, 1401/08/24
Registration timing:registered_while_recruiting
Last update:2022-11-15, 1401/08/24
Update count:0
Registration date
2022-11-15, 1401/08/24
Registrant information
Name
Seyedeh-saeedeh Yahyavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5471
Email address
saeedehyahyavi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-22, 1401/07/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The potential effect of transcranial direct current stimulation(tDCS) as an add-on to main-stream cognitive treatment in subjective cognitive impairment referring to cognitive clinics in Shiraz (َA sham-control study )
Public title
effect of transcranial direct current stimulation(tDCS) on treatment of subjective cognitive impairment(SCI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who have complaints about their cognitive functions
In performing cognitive tests, impairment can be seen in at least two cognitive areas
Exclusion criteria:
Presence of clinical diagnosis of any Neuropsychological and Neurological disorder in the patient's medical history
Drug abuse
Caffeine consumption in the last 12 hours before the primary test.
VAS scale > 5 before the primary test
Presence of sever attention and concentration disorder
Chronic sleep disorder
Using drugs with memory disturbances side effects
Sever Anxiety
History of head trauma
History of Head and Brain Surgery
Epilepsy
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the law of random allocation will be used, for this purpose, first, it is equal to the size of the total sample, we assign twenty papers with equal sizes to the groups of real and sham electrical stimulation with the codes A and B. Determining the group of people included in the study, a piece of paper is randomly removed from the container, they receive the real stimulation for code A and the B code receive sham stimulation. The removal of the papers will be without returning and replacing.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the people participating in the study do not know whether they are receiving a real tDCS or a sham tDCS, so that even in the sham group, the current is applied for thirty seconds with a less than effective intensity so that the person feels that he is performing an electrical stimulation to give It has become real. Also, in the continuation of the analyzers, he does not know about the grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shiraz university of medical science
Street address
Diamond Building, 29 Alley, Qasr al-Dasht Street
City
Shiraz
Province
Fars
Postal code
7133654361
Approval date
2021-12-05, 1400/09/14
Ethics committee reference number
IR.SUMS.REC.1400.655
Health conditions studied
1
Description of health condition studied
Subjective cognitive impairment (SCI) or a complaint about the cognitive inefficiency is defined as: the subjective dissatisfaction about cognitive function that have recently occurred, and this is despite the fact that there may be a problem from an objective point of view. and the quality of the person's life has not been affected
ICD-10 code
G32.8*
ICD-10 code description
subjective cognitive impairment, SCI, subjective memory impairment, SMI, subjective memory decline, SMD, transcranial direct current stimulation, tDCS
Primary outcomes
1
Description
The score obtained in RehaCom cognitive tests
Timepoint
The RehaCom cognitive test will be performed before the intervention and at the end of the ten treatment sessions.
Method of measurement
RehaCom, HASOMED, 1992-2021
2
Description
The score obtained in CANTAB cognitive tests
Timepoint
The CANTAB cognitive test will be performed before the intervention and at the end of the ten treatment sessions.
Method of measurement
CANTAB Research Suit software
Secondary outcomes
1
Description
sleep quality score
Timepoint
The sleep quality score of the participants will be measured by the Pittsburgh Sleep Quality Questionnaire before and after the treatment.
Method of measurement
The Pittsburgh Sleep Quality Index (PSQI)
Intervention groups
1
Description
Intervention group: transcranial direct current stimulation
Category
Treatment - Devices
2
Description
Control group: SHAM trans Cranial Direct Current Stimulation
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
dana brain health institute
Full name of responsible person
Mohammad Nami
Street address
unit 13,Maryam building, Besat Blvd., Shiraz,
City
shiraz
Province
Fars
Postal code
7133654361
Phone
+98 71 3230 7129
Fax
+98 71 3234 0072
Email
info@danabrain.ir
Web page address
https://danabrain.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammadreza Namavar
Street address
Headquarters of Shiraz, University of Medical Sciences, Zand Street, opposite Palestine Street, Shiraz
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://sums.ac.ir/Page-backupmain991001/en/448
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammadreza Namavar
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Headquarters of Shiraz University of Medical Sciences, Zand Street, opposite Palestine Street, Shiraz
City
Shiraz
Province
Fars
Postal code
1433671348
Phone
+98 71 3230 5410
Email
namavarm@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Nami
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Diamond Building, Alley 29, between Palestine and Mulla Sadra, Qasr al-Dasht St.
City
Shiraz
Province
Fars
Postal code
7133654361
Phone
+98 71 2300 7129
Email
Mtneurosci2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyedeh Saeedeh Yahyavi
Position
PhD student in neuroscience
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Alley 2,Tondgoyan Blvd
City
Shiraz
Province
Fars
Postal code
7168866138
Phone
+98 71 3834 1004
Email
saeedehyahyavi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data, such as information related to the main outcome or similar, can be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
data would be available only for people working in academic institutions
Under which criteria data/document could be used
The data will be available for researchers working in academic and scientific institutions for use in review and systematic articles.
From where data/document is obtainable
Applicants can contact the following email address and phone number to receive the desired documents or data.
saeedehyahyavi@Gmail.com
09174171293
What processes are involved for a request to access data/document
After sending an email and explaining how to use the data, if it is in accordance with the items mentioned here, the applicant can access the desired data after a maximum of two months.