Efficasy of transcranial direct current stimulation on dorsolateral prefrontal cortex on BDNF, IL-6, TNF- alpha
Design
After signing the consent form of participating in research, will randomly (on the web) be assigned in to three treatment groups (two real- stimulation groups and a sham group). The two real groups of 10 brain stimulation sessions in the DLPFC area and the sham group will receive 10 sham stimulation sessions in the same area.
Settings and conduct
After signing the consent form of participating in research, will randomly (on the web) be assigned in to three treatment groups (two real- stimulation groups and a sham group). The two real groups of 10 brain stimulation sessions in the DLPFC area and the sham group will receive 10 sham stimulation sessions in the same area.
Participants/Inclusion and exclusion criteria
Signing informed consent to participate in the research; Methadone treatment for at least two weeks before the intervention; age 18- 50 years old; minimum grade education. Exclusion criteria: absence of more than two sessions; suicidal thoughts or dangers that It is not possible to keep the dosage fixed; having severe psychiatric disorders such as schizophrenia; consuming multiple substance; history of injury to the head; history of epileptic seizures.
Intervention groups
Efficacy of transcranial direct current stimulation on dorsolateral prefrontal cortex on L-DLPFC, R-DLPFC and Sham.
Main outcome variables
Brain- derived neurotrophic factor (BDNF); interleukin 6 (IL-6); Tumor necrosis factor-( TNF-a); Quantitative EEG (QEEG); Desires for Drugs Questionnaire (DDQ); anxiety stress depression scale(DASS) and The ability to decision making
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033946N5
Registration date:2019-01-19, 1397/10/29
Registration timing:registered_while_recruiting
Last update:2019-01-19, 1397/10/29
Update count:0
Registration date
2019-01-19, 1397/10/29
Registrant information
Name
Mohsen Dadashi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3353 4500
Email address
mohsendadashi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficasy of transcranial direct current stimulation on dorsolateral prefrontal cortex on BDNF, IL-6, TNF-alpha
Public title
Efficasy of transcranial direct current stimulation on dorsolateral prefrontal cortex on BDNF, IL-6, TNF-alpha
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the research
Methadone treatment for at least two weeks before the intervention
Age 18- 50 years old
Minimum grade education
Exclusion criteria:
The absence of more than two sessions
Suicidal thoughts or dangers that It is not possible to keep the dosage fixed
Having severe psychiatric disorders such as schizophrenia
Consuming multiple substance
History of injury to the head
History of epileptic seizures
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
By online web software
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects will be evaluated by another examiner
Subjects will be assigned to groups without knowing about treatment groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
ZUMS Central Office: Azadi Square, Zanjan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45156-13113
Approval date
2018-08-14, 1397/05/23
Ethics committee reference number
IR.ZUMS.REC.1397.127
Health conditions studied
1
Description of health condition studied
Mental and behavioural disorders due to use of opioids
ICD-10 code
F11.1
ICD-10 code description
Opioid abuse with opioid-induced mood disorder
Primary outcomes
1
Description
Brain- derived neurotrophic factor (BDNF)
Timepoint
pretest-post test
Method of measurement
Eliza kit
Secondary outcomes
1
Description
interleukin 6 (IL-6)
Timepoint
pretest-post test
Method of measurement
Eliza kit
2
Description
Tumor necrosis factor-( TNF-a)
Timepoint
pretest-post test
Method of measurement
Eliza kit
3
Description
Quantitative EEG (QEEG)
Timepoint
pretest-post test
Method of measurement
Mitsar set
4
Description
BART Impassivity
Timepoint
pretest- post test
Method of measurement
BART Impassivity questionnaire
5
Description
Craving
Timepoint
pretest- post test
Method of measurement
Desires for Drugs Questionnaire (DDQ)
6
Description
sub scale anxiety -DASS
Timepoint
pretest- post test
Method of measurement
depression sub scale(DASS)
7
Description
decision making ablity
Timepoint
pretest-post test
Method of measurement
IUWA Gambling Task
Intervention groups
1
Description
Intervention group: There will be three groups. Two of them will be intervention groups and the other on will be sham group. One of the groups will receive Anodal tDCS treatment on R-DLPFC based on the protocol. This treatment consists of 10 sessions.
Category
Treatment - Devices
2
Description
Intervention group: This treatment consists of 6 sessions within two weeks. One of the groups will receive Cathodal tDCS treatment on L-DLPFC based on the protocol. This treatment consists of 10 sessions. This treatment consists of 6 sessions within two weeks.
Category
Treatment - Other
3
Description
Intervention group: The third group will sham tDCS but will be called the placebo effect of tDCS.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Behshti hospital
Full name of responsible person
Zakria Eskandari
Street address
Behshti hospital, Arq Square
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
Mohsendadashi@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shogli
Street address
ZUMS Central Office: Azadi Square, Zanjan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Phone
+98 24 3354 4001
Fax
Email
Shogli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Zakaria Eskandari
Position
ph.D student in adiction study
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Arq square-Beheshti hospital
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Email
mohsendadashi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zakaria eskandari
Position
phd student in addiction study
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Arq squre- Beheshti hospital
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4001
Email
Mohsendadashi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zakaria Eskandari
Position
phd student in addiction study
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Arq square- Behshti hospital
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
Mohsendadashi@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Not complete
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available