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

Not Applicable

Interventions: Device: tDCS
Device: Sham brain stimulation
Behavioral: Go-No GO task

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
tDCS and Go-No Go task	tDCS	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
tDCS and Go-No Go task	Go-No GO task	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
Sham brain stimulation and Go-No Go task	Go-No GO task	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
Sham brain stimulation and Go-No Go task	Sham brain stimulation	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

Primary Outcome Measures

Name	Time	Method
Change in Yale Food Addiction Scale scores	Scores measured at baseline and at up-to 2 weeks after the intervention	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).
Change in Three-Factor Eating Questionnaire scores	Scores measured at baseline and at up-to 2 weeks after the intervention	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).

Secondary Outcome Measures

Name	Time	Method
Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)	Brain MRS at baseline and up-to 2 weeks after the intervention	Significant change in brain metabolites concentration at the prefrontal cortex (area involved in the inhibitory control of food intake) measured with Magnetic Resonance spectroscopy
Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI)	Brain function at baseline and up-to 2 weeks after the intervention	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

Locations (1): University of California
🇺🇸
Los Angeles, California, United States