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IRCT20121020011172N4 IRCT 2020-06-04 Cognitive Sciences & Technologies Council Examining the effect of electrical brain stimulation on food cue-induced craving by MRI 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 2020-02-19 anticipated 65 Complete https://irct.ir/trial/45482 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, 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 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. N/A Food craving and obesity. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The process of publication will be specified.
public Dr Hamed Ekhtiari
Laureate Institute for Brain Research 6655 South Yale Avenue
Tulsa United States of America 74136-3326 001 918 502 5100 hekhtiari@laureateinstitute.org Laureate Institute for Brain Research scientific Dr. Hamed Ekhtiari
Laureate Institute for Brain Research 6655 South Yale Avenue
Tulsa United States of America 74136-3326 001 918 502 5100 h.ekhtiari@gmail.com Laureate Institute for Brain Research Iran (Islamic Republic of) 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 18 years 61 years Both 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 E66 Overweight and obesity Other Placebo 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. 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. 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. 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). 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. 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). 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. 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. 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?". Desire for Food Self Report. Timepoint: Before and after of intervention. Method of measurement: Response to the Food Craving Questionnaire (FCQ). Cognitive Sciences & Technologies Council Approved 2018-02-12 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN Tehran Tehran Iran (Islamic Republic of)