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A study of the effectiveness of a tDCS session in controlling craving for cigarette smoking

Protocol summary

Study aim
A study of the effectiveness of a tDCS session in controlling craving for cigarette smoking
Design
Control group, with parallel groups, single blind, randomized
Settings and conduct
This study is a clinical trial conducted in people with craving who are referred to Firoozgar Hospital. Patients are randomly divided into control and tDCS treatment groups. The excitation current is generated by a direct current generating device with a maximum voltage of 4 mA. In the intervention group, the subjects receive 2 mA for 20 minutes. Like the active excitation band, after the electrodes are inserted into the device It turns on and off after a few seconds and the ramp up is completed by the hospital and the patient receives no electrical stimulation.
Participants/Inclusion and exclusion criteria
Inclusion: Healthy people between the ages of 18 and 55, active smokers (at least 10 cigarettes daily) at least one yearEpilepsy, history of Cerebral Stroke, Exclusion: Stroke, Cerebral Surgery, Psychiatric Disorders, Antipsychotic Drug Use, Pregnancy, use (Alcohol; Cocaine; Amphetamine),History of cigarette withdrawal receiving treatment for withdrawal, A history of decreased consciousness for more than 15 minutes, metal objects in the body such as a cochlear implant heart rate monitor, a history of seizures.
Intervention groups
. All patients are electrodes placed on the left DLPFC region and on the right DLPFC catheter. The excitation current is produced by a direct current generating device with a maximum voltage of 4 mA. In the intervention group, subjects receive 2 mA for 20 minutes. In the control group, as in the active stimulation group, the electrodes are turned on after the electrodes are inserted in the device, and after a few seconds, the ramp up is euthanized by the hospital, and the patient receives no electrical stimulation.
Main outcome variables
Reduce craving for cigarettes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170910036107N5
Registration date: 2020-05-02, 1399/02/13
Registration timing: prospective

Last update: 2020-05-02, 1399/02/13
Update count: 0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Naseh Yousefi
Name of organization / entity
Iran university of medical science and health services
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 6574
Email address
nasehusefi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study of the effectiveness of a tDCS session in controlling craving for cigarette smoking
Public title
Effect of tDCS on smoking craving control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy people between the ages of 18 and 55 active smokers (at least 10 cigarettes daily) for at least one year
Exclusion criteria:
Epilepsy history of Cerebral Stroke Stroke Cerebral Surgery Psychiatric Disorders Antipsychotic Drug Use Pregnancy useing (Alcohol; Cocaine; Amphetamine) History of cigarette withdrawal or received treatment for withdrawal history of decreased consciousness over 15 minutes metal objects such as heart rate monitor, cochlear implant history of seizures
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: block Unit of randomization: individual Tools used in randomization such as table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the patient , it is said that tDCS is effective in controlling cravings for smoking, but the control and intervention group is not mentioned.
Placebo
Not 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
valiasr Square, Alley to Afrin, Firoozgar Hospital
City
Tehran
Province
Tehran
Postal code
1593747811
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.IUMS.FMD.REC.1398.153

Health conditions studied

1

Description of health condition studied
Effectiveness of a tDCS session in controlling smoking craving
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
FTND questionnaire on smoking craving
Timepoint
The temptation to smoke before and immediately after the intervention
Method of measurement
FTND questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the intervention group, subjects receive 2 mA for 20 minutes
Category
Rehabilitation

2

Description
Control group: The Control group Like the active stimulation group, the electrodes are turned on after the electrodes are inserted and after 30 seconds they are switched off and receive no stimulation
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Marjan Fallah
Street address
Valiasr Square - Afrin Alley - Firoozgar hospital
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
marjan.fallah9594@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Abbas Motevaliyan
Street address
Department of Physical Medicine and Rehabilitation, Firoozgar Hostpital,Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
marjan.fallah9594@gmail.com
Grant name
Research center of Physical Medicine and Rehabilitation
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
Marjan Fallah
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Department of Physical Medicine and Rehabilitation, Firoozgar Hostpital,Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
matjan.fallah9594 @gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naseh Usefi
Position
Associate Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firoozgar Hostpital,Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
Nasehusefi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marjan Fallah
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Valiasr Square - Afrin Alley - Firoozgar Hospital
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1600
Email
marjan.fallah9594@gmail.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
All the patient's data can be shared with privacy in regard to patients name
When the data will become available and for how long
Start accessing 6 months after publishing the results.
To whom data/document is available
For scholars working in academic centers.
Under which criteria data/document could be used
It can be analyzed and printed by other people by mentioning the source.
From where data/document is obtainable
Marjan fallah,98113229421,marjan.fallah9594@gmail.com
What processes are involved for a request to access data/document
Upon authentication,data is provided to the individual.
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