The evaluation of moral decision making and its coherence with risky decision making and Sociocognitive profile in the patients with brain injuries (traumatic and stroke), before and after Transcranial direct current stimulation (tDCS), in comparison to Sham group.
assessment of Transcranial direct current stimulation (tDCS) on moral decision making in aim to better understand Neuro-anatomic network of moral decision making in brain
Design
In this clinical trial, randomized controlled trial are conducted on total 20 individuals dividing into two groups of 10 for stimulation and 10 without any.Randomization is individualized and simple. Analyzers and participants are not informed about whether a person is in the control group or in the trial group.
Settings and conduct
patients would be first assessed in Rasoul and firoozgar hospitals then referred to brain clinic for intervention.participants and analyzers are blinded in this study.
Participants/Inclusion and exclusion criteria
inclusion criteria:
finishing middle school.
no sever behavioral problem interfering with the project.
no physical restriction interfering with the project.
good drug compliance.
no substance use disorder in the last month.
no change in psychiatric medication in last month.
no psychiatric hospitalization in the last moth.
exclusion criteria :
delirium or decrease in level of consciousness in time of the project.
prominent aphasia.
acute mood or psychotic phase.
schizophrenia.
acute intoxication.
severe cluster B personality disorder.
sever cognitive impairment interfering with the project.
uncontrolled seizure.
neurosurgery of brain with prominent skull deficit.
acute intracranial hemorrhage.
Intervention groups
we will use high definition transcranial direct current stimulation for the intervention group fulfilling inclusion criteria. Used protocol will be based on similar studies for behavioral interventions. the placement of electrodes will be on dorsolateral prefrontal cortex.In control group in spite of electrode placement no stimulation is used.
Main outcome variables
moral decision making,empathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191016045135N1
Registration date:2020-11-23, 1399/09/03
Registration timing:retrospective
Last update:2020-11-23, 1399/09/03
Update count:0
Registration date
2020-11-23, 1399/09/03
Registrant information
Name
Fatemeh Sadat Mirfazeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2331
Email address
f_m_tums@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of moral decision making and its coherence with risky decision making and Sociocognitive profile in the patients with brain injuries (traumatic and stroke), before and after Transcranial direct current stimulation (tDCS), in comparison to Sham group.
Public title
impact of Transcranial direct current stimulation (TDCS) on moral decision making in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
finished middle school
medication compliance
no change in medication in last month
no psychiatric hospitalization over the last month
Exclusion criteria:
decrease in level of consciousness
prominent aphasia
acute phase of mood or psychotic episode
substance use disorder in the last month
antisocial or borderline or narcissistic personality disorder
severe cognitive impairment interfering cooperation in the intervention
uncontrolled seizure
active intracranial hemorrhage
brain neurosurgery with prominent skull deficit
schizophrenia diagnosis
Age
From 17 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
A number of 20 participants with moral decision making impairment in divided into two groups of 10 people based on simple randomization by table of random numbers. one group of 10 will receive sham while the other will receive TDCS.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the current study, participants are blind to the situation whether they are receiving electrical stimulation through tDCS or not. Before undergoing tDCS, the process will be properly explained to the patients. For some patients the electrodes of tDCS will be placed on the scalp without any electrical stimulation. Data analyzer and outcome assessors are also unaware of which participant has received electrical stimulation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
IR.IUMS.REC.1398.633
Health conditions studied
1
Description of health condition studied
Traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
2
Description of health condition studied
Brain stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Moral decision making score
Timepoint
Before intervention and within 1 hour of intervention
Method of measurement
Moral vignettes prepared by Knutson et al
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive Transcranial direct current stimulation (tDCS).
Category
Treatment - Devices
2
Description
Control group: Sham: the electrodes of tDCS device will be placed on the skull of this group without any electrical stimulation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-Akram Hospital
Full name of responsible person
Fatemeh Sadat Mirfazeli
Street address
School of Behavioral Sciences and Mental Health ,mental health research center Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
f_m_tums@yahoo.com
2
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Fatemeh Sadat Mirfazeli
Street address
School of Behavioral Sciences and Mental Health ,mental health research center Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
f_m_tums@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Abbas motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Mirfazeli
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN