Evaluation of tDCS (transcranial direct current stimulation) effect on traumatic brain injuries patients
Design
Two arms parallel-group randomized trial with blinded outcome assessment
Settings and conduct
In Loghman hakim hospital ten session of tDCS in right dorsolateral prefrontal cortex will be done. ethical decision making test will be done after and before treatment but the researcher who do this evaluation is not aware of which person receive the tDCS.
Participants/Inclusion and exclusion criteria
Inclusion criteria: traumatic brain injury base on brain CT scan ( except occipital lobar injury؛ education: more than primary school؛ age (18-65)؛ man and woman
Exclusion criteria: any loss of consciousness or delirium base on clinical history؛ presence of aphasia؛ acute phase of mood or psychotic disorder base on semi-structure interview؛ acute phase of substance abuse؛ anti social, borderline or narcissistic personality disorder base on DSM5 SCID II semi-structure interview؛ severe cognitive disorder base on Montreal Cognitive Assessment score less than 10
Intervention groups
Traumatic brain injury patients are randomly divided into two groups: 1. Group 1 who receive tDCS and 2. group 2 who don't receive tCDS
Main outcome variables
Ethical decision making test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220531055042N1
Registration date:2022-08-30, 1401/06/08
Registration timing:registered_while_recruiting
Last update:2022-08-30, 1401/06/08
Update count:0
Registration date
2022-08-30, 1401/06/08
Registrant information
Name
Hossein Pakdaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 0044
Email address
bmrc@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-11, 1401/04/20
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Transcranial direct-current stimulation(tDCS) on moral decision making in patients with traumatic brain injury
Public title
Transcranial direct-current stimulation(tDCS) on moral decision making in patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Brain trauma based on brain CT scan findings (other than injuries in the occipital lobe)
Exclusion criteria:
Any decrease in level of consciousness or delirium based on clinical history
Existence of aphasia
Acute mood or psychotic phase based on semi-structured interview ُ
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table
Block random sampling will be used. In the present study, there are two groups (intervention group and control group). Therefore, four blocks will be used. According to the sample size (28 people in total, 14 in each group), 7 blocks of four will be considered. The random allocation of individuals to the group's understudy will be done as follows: First, there are 7 envelopes containing four cards with ABCD Latin letters, the letters A and B = the intervention group, the letters C and D = will be considered as the control group. According to the inclusion criteria, the patients were asked to choose one of the 7 seals envelopes randomly and select a random card from the inside, which is based on the card's adhesive that determines the allocation of the individual to either of the two study groups
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be conducted as a single-blinded manner in which the evaluating researcher is not aware of which patients received the Transcranial direct-current stimulation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Loghman hakim Hospital, South Karegar St.
City
Tehran
Province
Tehran
Postal code
1764665645
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.067
Health conditions studied
1
Description of health condition studied
Neurology
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Ethical decision making
Timepoint
At the time of admission (before intervention) and after 30 days & 60 days after intervention
Method of measurement
Questionnaire (ethical decision making test)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: traumatic brain injury patients who received transcranial direct current stimulation. In Loghman hakim hospital ten session of tDCS (transcranial direct current stimulation) in 20 minutes in right dorsolateral prefrontal cortex will be done.
Category
Treatment - Other
2
Description
Control group: traumatic brain injury patients who do not receive treatment
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman hakim hospital
Full name of responsible person
Hossein pakdaman
Street address
Loghman hakim hospital, kamali Ave, South kargar, tehran
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
hpakdaman@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein pakdaman
Street address
Loghman hakim hospital, kamali Ave, South kargar, tehran
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
hpakdaman@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein pakdaman
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Loghman hakim hospital, kamali Ave, South kargar, tehran
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
hpakdaman@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein pakdaman
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Loghman hakim hospital, kamali Ave, South kargar, tehran
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
hpakdaman@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein pakdaman
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Loghman hakim hospital, kamali Ave, South kargar, tehran
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Email
hpakdaman@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, which is the main consequence of the study
When the data will become available and for how long
Starting to access the data after 6 months of publishing the result
To whom data/document is available
researchers working in academic and industrial institutions
Under which criteria data/document could be used
Therapeutic usage
From where data/document is obtainable
Hossein pakdaman, hpakdaman@sbmu.ac.ir
What processes are involved for a request to access data/document
After submitting the request and checking the available items, the data is obtained