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The effect of trans cranial direct current stimulation of the brain(tdcs)on smoking cessation in patients with bipolar mood disorder in depressive phase

Protocol summary

Study aim
Evaluation of the effect of trans cranial direct current stimulation of the brainon smoking cessation in hospitalized patients with bipolar disorder
Design
This is a clinical trial study in which patients with bipolar disorder in the depressive phase referred to Amirkabir Hospital in Arak who meet the inclusion criteria are included in the study. In this study, 28 patients were randomly divided into intervention and control groups.
Settings and conduct
In this clinical trial study, patients with bipolar disorder in the depressive phase referred to Amirkabir Hospital in Arak are included in the study. In this study, 28 patients were randomly divided into intervention and control groups. In the intervention group, direct electrical brain stimulation was performed with tDCS device (with current of 2 mA for 20 minutes every day ). In the control group, electrodes are attached to the patient's head but no stimulation occurs. Finally, the two groups are compared in terms of the severity of nicotine dependence symptoms (Nicotine Dependence Syndrome Scale Questionnaire) and the severity of depression (Montgomery-Asberg Depression Rating Scale).
Participants/Inclusion and exclusion criteria
Age 20-60 years, The existence of bipolar disorder criteria in the depression phase based on DSM V criteria, Lack of mental retardation, Lack of Epilepsy, dementia, delirium and other cognitive disorders, No Pregnancy, Lack of medical diagnosis has been shown to cause problems in the study process
Intervention groups
In the intervention group, transcranial direct current stimulation is performed with tDCS device (with the current of 2 mA for 20 minutes every day for 10 sessions) . In Control group: In this group, the electrodes of the TDCS device are connected to the head, but no electrical stimulation takes place
Main outcome variables
The severity of nicotine dependence symptoms ؛ Severity of depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200614047771N1
Registration date: 2021-01-30, 1399/11/11
Registration timing: retrospective

Last update: 2021-01-30, 1399/11/11
Update count: 0
Registration date
2021-01-30, 1399/11/11
Registrant information
Name
arghavan zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3403 3094
Email address
arghavan.dr13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of trans cranial direct current stimulation of the brain(tdcs)on smoking cessation in patients with bipolar mood disorder in depressive phase
Public title
The effect of direct electrical stimulation of the brain on reducing smoking in patients with bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-60 years The existence of bipolar disorder criteria in the depression phase based on DSM V criteria Lack of medical diagnosis has been shown to cause problems in the study process
Exclusion criteria:
Pregnancy mental retardation Epilepsy, dementia, delirium and other cognitive disorders
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using envelopes in the division of intervention and control groups - in this method, a number of cards or letters are selected by the researcher as the intervention group and the same number as the control group. The group related to each card It is written on it. These cards are in the envelope so that the group related to it is not specified. Then these letters were mixed and folded and then according to the order of patients entering the study, a card was issued for each patient and its allocation was recorded and the card was returned to all other cards after expiration. Then we mix and pick again and take out a new card for the next patient. This process continues until the last patient.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.ARAKMU.REC.1399.078

Health conditions studied

1

Description of health condition studied
bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder

2

Description of health condition studied
Cigarette addiction
ICD-10 code
F17.21
ICD-10 code description
Nicotine dependence, cigarettes

Primary outcomes

1

Description
The severity of nicotine dependence symptoms
Timepoint
Nicotine dependence at the beginning of the study and after 10 sessions of tdcs
Method of measurement
Nicotine dependence syndrome scale(NDSS)

2

Description
Severity of depression
Timepoint
Severity of depression at the beginning of the study and after 10 sessions of tdcs
Method of measurement
Montgomery-asberg depression rating scale

Secondary outcomes

empty

Intervention groups

1

Description
Both groups are treated with mood-stabilizing drugs (sodium valproate-lithium - antipsychotic) which are prescribed according to the patient's condition.In the intervention group, transcranial direct current stimulation is performed with tDCS device (with the current of 2 mA for 20 minutes every day for 10 sessions)
Category
Treatment - Devices

2

Description
Both groups are treated with mood-stabilizing drugs (sodium valproate-lithium - antipsychotic) which are prescribed according to the patient's condition. In the control group, electrodes of the TDCS device are attached to the head but no electrical stimulation takes place.connected to the head, but no electrical stimulation takes place.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Amirkabir hospital
Full name of responsible person
Dr Anita Alaghemand
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alaghemand@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Vice chancellor for Research, Arak University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Mohsen Ghasemi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
ghasemi@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Anita Alaghemand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Alaghemand@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Arghavan zarei
Position
Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
Arghavan.dr13@yahoo.com

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
When the article was out of print.
When the data will become available and for how long
After publishing the article
To whom data/document is available
University researchers
Under which criteria data/document could be used
If there are any further questions
From where data/document is obtainable
Dr Anita Alaghemand
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.
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