Clinical trials of The effectiveness of transcranial direct current stimulation (tDCS) on food craving and implicit memory bias associated with food in people with food craving
The aim of this study is to evaluate the effectiveness of transcranial direct current stimulation on food craving and implicit memory associated with food. Study population are all male students of Semnan University who have food craving. The number of participants is considered 20. Random numbers table was used to assign each member to the control and experimental groups. In this study, a randomized single-blind, placebo-controlled (Sham electrical stimulation) design was used. Inclusion criteria: Age range between 18 and 70 years; obtaining the food craving score at least one standard deviation higher than population mean; the body mass index (BMI) less than 40. Exclusion criteria: a history of eating disorders or depression, suicide attempts; having metal implants in the head; drug induced weight loss; having recently participation in the weight-loss programs; having an individual or family history of epilepsy; using any drugs intended to reduce seizure thresholds; a history of head surgery and loss of consciousness for more than 15 minutes; and having a history of endocrine disorders.
Direct transcranial stimulation using 5 × 7 cm anodic and cathodic electrodes with 2 MA electrical velocity was applied in one 20-minute Session. The anode electrode is placed on the right side of the head in the dorsolateral prefrontal cortex (DLPFC), F4 region in the 10-20 system and cathode electrode is placed on the left side of the head, dorsal lateral prefrontal cortex (DLPFC), F3 region in the 10-20 system. The electrodes are soaked in a solution of sterile 0.9% sodium chloride. Outcomes: craving and memory.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016120331217N1
Registration date:2017-02-08, 1395/11/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-08, 1395/11/20
Registrant information
Name
Ebrahim Zeylabi Sandegani
Name of organization / entity
Semnan University
Country
Iran (Islamic Republic of)
Phone
+98 38 3448 0028
Email address
ebrahimzeylabi@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Psychology, University of Semnan
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials of The effectiveness of transcranial direct current stimulation (tDCS) on food craving and implicit memory bias associated with food in people with food craving
Public title
The effectiveness of transcranial direct current stimulation (tDCS) on food craving and implicit memory bias associated with food
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age range between 18 and 70 years; obtaining the food craving score at least one standard deviation higher than population mean; the body mass index (BMI) less than 40. Exclusion criteria: a history of eating disorders or depression, suicide attempts; having metal implants in the head; drug induced weight loss; having recently participation in the weight-loss programs; having an individual or family history of epilepsy; using any drugs intended to reduce seizure thresholds; a history of head surgery and loss of consciousness for more than 15 minutes; and having a history of endocrine disorders.
Age
From 18 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Psychology Department, Semnan University
Intervention group: The intervention was consisted of 40 mA electrical stimulation (2 mA per minute for 20 minutes). This amount of stimulation was delivered to the patients in a twenty-minute session. In this intervention the left and right dorsolateral prefrontal cortex of participants were stimulated.
Category
Treatment - Devices
2
Description
Control group: The left and right dorsolateral and prefrontal cortexes were stimulated through Sham stimulation in the control group. The Sham stimulation has placebo-like effects. This stimulation was performed on the participants’ heads for 20 minutes
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan University Counseling Center
Full name of responsible person
Dr Parviz Sabahi
Street address
Semnan University Counseling Center, Daneshkade Fanni street, Standard Square
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University
Full name of responsible person
Dr Parviz Sabahi
Street address
Deputy of Research and Technology, Semnan University, Saadi squre
City
Semnan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Semnan University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Ebrahim Zeylabi Sandegani
Position
MA clinical Psychology
Other areas of specialty/work
Street address
No 8, Bahar Alley, Pasdaran street, Shahreza, Esfahan
City
Shahreza
Postal code
8895151311
Phone
+98 23 3362 3300
Fax
+98 23 3362 3300
Email
ebrahimzeylabi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Psychology, Semnan University
Full name of responsible person
Ebrahim Zeylabi Sandegani
Position
MA in Clinical Psychology
Other areas of specialty/work
Street address
No 8, Bahar Alley, Pasdaran street, Shahreza, Esfahan
City
Shahreza
Postal code
8895151311
Phone
+98 23 3362 3300
Fax
Email
ebrahimzeylabi@yahoo.comp; sabahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Ebrahim zeylabi Sandegani
Position
MA in Clinical Psychology
Other areas of specialty/work
Street address
No 8, Bahar Alley, Pasdaran street, Shahreza, Esfahan
City
Shahreza
Postal code
8895151311
Phone
+98 38 3448 0028
Fax
-
Email
ebrahimzeylabi@yahoo.comp; sabahi@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)