The Effect of Brain Stimulation (tDCS) in Food Cravings Control in Overweight/Obese Women

Study Overview
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Brief Summary
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This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS). All eligible participants will engage in a behavioral intervention known to enhance control over food cravings and will be randomly assigned to receive either tDCS or sham stimulation to the prefrontal cortex of the brain.

Detailed Description
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This study is a randomized clinical trial to test the effect of a type of non-invasive brain stimulation on the response to a behavioral intervention designed to enhance cognitive control over food cravings in obese and overweight women. The brain stimulation is called transcranial Direct Current Stimulation (tDCS) which is a form of stimulation that delivers a low amplitude electrical current to the brain via the scalp (i.e. trans-cranial) to modify brain activity. All eligible participants will engage in a behavioral intervention (Go-No Go task), known to enhance control over food cravings, and will be randomly assigned to receive either tDCS or sham stimulation to the right prefrontal cortex of the brain during 8 20-min daily sessions. Primary outcome: score changes in eating behaviors scales (YFAS and TFEQ), scales will be applied at baseline and at the end of the 8 brain stimulation sessions. Secondary outcomes: changes in diet, brain function (brain MRI/MRS) Other outcomes: food cravings scales and impulse control scales and cognitive function.

Official Title
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The Effect of Brain Neuromodulation on Food Cravings, Cognitive Control and Food Addiction Scales in Overweight/Obese Women Using tDCS

Conditions
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Obesity

Intervention / Treatment
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* Device: tDCS
* Device: Sham brain stimulation
* Behavioral: Go-No GO task


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 28 and 40 kg/m2 high scores in the Yale-Food Addiction-Scale right-handed Exclusion Criteria: History of anorexia nervosa or bulimia or binge eating disorder Any contraindication to undergo MRI Use of psychotropic medications and/or opiate pain medications. Current or past alcohol or drug abuse problem or smoking Pregnancy Current use of weight loss medication or currently participating in a weight loss program. History of seizures, epilepsy or factors/medications associated with lowered seizure threshold. History of brain disease or major neurological disorder or mental disorder History of brain surgery or history of loss of consciousness >15 min History of major gastrointestinal surgery including weight loss surgery History of endocrine imbalances including diabetes, thyroid disease, Cushing's disease, metabolic syndrome and polycystic ovary.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS and Go-No Go task<br>Certain randomly assigned participants will receive tDCS to the DLPFC for 8 daily 20-minute sessions, with a TDCS amplitude of 2 mAmps. During the tDCS session, individuals will perform a 10-min computerized Go-No Go task | Device: tDCS<br>* Individuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex)<br>* Other names: Real brain stimulation;Behavioral: Go-No GO task<br>* During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go)<br>|
| Sham Comparator: Sham brain stimulation and Go-No Go task<br>Certain randomly assigned participants will receive Sham Stimulation to the DLPFC for 8 daily 20-min sessions. The Sham stimulation is an inactive form of stimulation. During the sham brain stimulation session, individuals will perform a 10-min computerized Go-No Go task | Device: Sham brain stimulation<br>* Individuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex)<br>Behavioral: Go-No GO task<br>* During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Yale Food Addiction Scale scores | Yale Food Addiction Scale (YFAS26) that is a 25-item measure developed to measure food addiction. Score range: 0 to 7. Higher scores in the scale mean more symptoms resembling food addiction (worse). | Scores measured at baseline and at up-to 2 weeks after the intervention | 
| Change in Three-Factor Eating Questionnaire scores | Three-Factor Eating Questionnaire is a validated scale that is designed to measure 3 dimensions of human eating behavior: cognitive restraint of eating (Factor I), disinhibition (Factor II), and hunger (Factor III). The minimum score for factors I-II-III is therefore 0-0-0, and maximum possible score is 20-16-15. Higher scores in the respective scales are indicative of greater cognitive restraint (better), uncontrolled (worse), or emotional eating (worse). | Scores measured at baseline and at up-to 2 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI) | Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI evoked responses to visual food-cues | Brain function at baseline and up-to 2 weeks after the intervention | 
| Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS) | Significant change in brain metabolites concentration at the prefrontal cortex (area involved in the inhibitory control of food intake) measured with Magnetic Resonance spectroscopy | Brain MRS at baseline and up-to 2 weeks after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food cravings, neuromodulation, brain, cognitive control, tDCS, prefrontal cortex, MRI, food addiction