Protocol summary

Study aim
To determine whether transcranial direct current stimulation (tDCS) over dorsolateral prefrontal cortex (DLPFC) changes subcortical limbic reactivity to food cues in obesity
Design
a double-blind randomized controlled trial with two parallel arms
Settings and conduct
This study will be conducted at the National Brain Mapping Lab, Tehran, Iran. Participants who meet all inclusion and exclusion criteria, that previously defined, will enter the study. All participants have a unique code during the study and the group allocation remains indistinguishable to both participants and the investigators. The screen of the tDCS device doesn’t display information about stimulation parameters.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age ≥18 and <61 years old 2. Persian speaking 3. BMI: 25-35 4. Frequent food cravings (≥3times/day during last month) in the screening self-report 5. Positive response to food cue-reactivity screening (≥ 50% craving in visual analog scale) Exclusion criteria: 1. Unwillingness or inability to complete any of the major aspects of the study protocol, including magnetic resonance imaging, food cue rating, or behavioral assessment. 2. Comorbid severe psychiatric disorders or unstable medical disorder which are evaluated by a specialist. 3. History of brain injury or seizure 4. History of any brain stimulation
Intervention groups
The current level used for the study will not exceed 2mA. The stimulator ramps up the current over 30 seconds. In the sham setting, the current is ramped down again. In the real setting, the current stays at the same level. The stimulation will proceed for 20 minutes, at which point the current is slowly ramped down over 30 seconds.
Main outcome variables
Primary Outcome Measures: 1. Blood oxygen level dependent (BOLD) signal changes in contrast between food and non-food images 2. Food Craving Self Report

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121020011172N4
Registration date: 2020-06-04, 1399/03/15
Registration timing: retrospective

Last update: 2020-06-04, 1399/03/15
Update count: 0
Registration date
2020-06-04, 1399/03/15
Registrant information
Name
Hamed Ekhtiari
Name of organization / entity
The center of molecular and cellular imaging
Country
Iran (Islamic Republic of)
Phone
+98 21 2640 3626
Email address
h_ekhtiari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-19, 1398/11/30
Expected recruitment end date
2020-05-18, 1399/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Modulation of Psychological and Neural Response for Food Craving among People with Obesity Using Transcranial Direct Current Stimulation (tDCS) on Dorsolateral Prefrontal Cortex (DLPFC): A Randomized Clinical Trial
Public title
Examining the effect of electrical brain stimulation on food cue-induced craving by MRI
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age ≥18 and <61 years old2. Persian speaking3. BMI: 25-354. Frequent food cravings (≥3times/day during last month) in the screening self-report5. Positive response to food cue-reactivity screening (≥ 50% craving in visual analog scale)6. Willing and capable of interacting with the informed consent process
Exclusion criteria:
1. Unwillingness or inability to complete any of the major aspects of the study protocol, including magnetic resonance imaging (i.e., due to claustrophobia), food cue rating, or behavioral assessment.2. Comorbid severe psychiatric disorders (e.g. severe depression, bipolar, psychosis or background of suicide) Which is evaluated by a specialist.3. Active suicidal ideation with intent or plan determined by self-report or assessment by PI or study staff during the initial screening or any other phase of the study 4. Any active skin disorder that affects skin integrity of the scalp 5. Unstable medical disorder reported in subject’s medical history or by a clinician assessment6. Non-correctable vision or hearing problems7. History of brain injury or seizure 8. History of any brain stimulation 9. Any other condition the PI or study staff feel would put the subject at risk for entering the study
Age
From 18 years old to 61 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 65
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be a randomized block design with 6 blocks, the sequence of randomization will be determined through sealedenvelope.com site and based on this, the researcher considers eligible subjects for the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The subject and researcher is not aware of the actual or sham stimulation. In fact, the screen of the device is the same in both cases (real stimulation or sham) and only the supervisor is aware of the type of intervention.
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
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-02-12, 1396/11/23
Ethics committee reference number
IR.IUMS.REC.1396.0459

Health conditions studied

1

Description of health condition studied
Food craving and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Blood oxygen level dependent (BOLD) signal changes in the contrast between food and non-food images
Timepoint
Before and after of intervention
Method of measurement
BOLD signal differences with voxel-wise analysis in the regions of interests (ROIs) (Prefrontal cortex, Insula, Striatum, Thalamus and Extended Amygdala) in craving > neutral contrast in event-related design food cue exposure fMRI task

2

Description
Food Craving Self-Report
Timepoint
Before and after of intervention
Method of measurement
Subjective response to "On a scale of 0-100, How much "food craving" are you experiencing RIGHT NOW" measured on a visual analog scale (0-100)

Secondary outcomes

1

Description
Cortical-Subcortical Connectivity in Resting State fMRI
Timepoint
Before and after of intervention
Method of measurement
Correlation between resting-state average Blood oxygen level dependent (BOLD) signal time series in subcortical ROIs and voxels within prefrontal cortex and Insula

2

Description
Cortical-Subcortical Task-based Connectivity in Cue Exposure fMRI
Timepoint
Before and after of intervention
Method of measurement
Psychophysiological Interaction (PPI) between average blood oxygen level dependent (BOLD) signal time series in subcortical ROIs and voxels within prefrontal cortex and Insula measured before and after tDCS (active and sham)

3

Description
RAI )Allocation Index (RAI) in Resting State fMRI
Timepoint
Before and after of intervention
Method of measurement
The correlation among default mode network (DMN), saliency network (SN) and Executive Control Network (ECN) in resting state fMRI

4

Description
Area Under Electrode Connectivity in Resting State fMRI
Timepoint
Before and after of intervention
Method of measurement
Voxel-wise Psychophysiological Interaction (PPI) between average blood oxygen level dependent (BOLD) signal in the cortical area under the Anode electrode and whole brain in craving > neutral contrast in event-related designfood cue exposure fMRI task

5

Description
Food Craving Control Self-Report
Timepoint
Before and after of intervention
Method of measurement
Subjective response to "On a scale of 0-100, How much "control" do you feel you have over your "food craving" RIGHT NOW?"

6

Description
Desire for Food Self Report
Timepoint
Before and after of intervention
Method of measurement
Response to the Food Craving Questionnaire (FCQ)

Intervention groups

1

Description
Intervention group (active tDCS): The current level used for the study will not exceed 2mA. The stimulator ramps up the current over 30 seconds. In the sham setting, the current is ramped down again. In the real setting, the current stays at the same level. The stimulation will proceed for 20 minutes, at which point the current is slowly ramped down over 30 seconds.
Category
Other

2

Description
Control group (sham tDCS): The stimulator ramps up the current over 30 seconds and then the current is slowly ramped down over 30 seconds. The set-up for sham and real stimulation sessions are exactly the same.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran National Brain Mapping Centre
Full name of responsible person
Nastaran Malmir
Street address
NBML, South Side of the Electrical Engineering Faculty, College of Engineering, North Kargar St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1439957131
Phone
+98 21 8609 3109
Email
info@nbml.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cognitive Sciences & Technologies Council
Full name of responsible person
Dr Hamed Ekhtiari
Street address
No 35, CSTC Building, Alvand St, Argentina Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
88194954
Phone
+98 21 8819 4956
Email
info@cogc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cognitive Sciences & Technologies Council
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Laureate Institute for Brain Research
Full name of responsible person
Dr Hamed Ekhtiari
Position
Associate Investigator-Laureate Institute for Brain Research
Latest degree
Specialist
Other areas of specialty/work
Neuroimaging
Street address
Laureate Institute for Brain Research 6655 South Yale Avenue
City
Tulsa
Province
Tulsa
Postal code
74136-3326
Phone
001 918 502 5100
Fax
Email
hekhtiari@laureateinstitute.org
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Laureate Institute for Brain Research
Full name of responsible person
Dr. Hamed Ekhtiari
Position
Associate Investigator
Latest degree
Specialist
Other areas of specialty/work
Neuroimaging
Street address
Laureate Institute for Brain Research 6655 South Yale Avenue
City
Tulsa
Province
Tulsa
Postal code
74136-3326
Phone
001 918 502 5100
Fax
Email
h.ekhtiari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iranian National Center for Addiction Studies (INCAS)
Full name of responsible person
Nastaran Malmir
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iranian National Center for Addiction Studies (INCAS), Farabi Hospital, Qazvin Square, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1635713366
Phone
+98 21 5542 1155
Fax
Email
nastaranmalmir@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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