The Effect of Brain Neuromodulation on Food Cravings, Cognitive Control and Food Addiction Scales in Overweight/Obese Women Using tDCS
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Change in Yale Food Addiction Scale scores
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Change in Yale Food Addiction Scale scores
Time Frame: 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
Time Frame: 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 Outcomes
- Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)(Brain MRS at baseline and up-to 2 weeks after the intervention)
- Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI)(Brain function at baseline and up-to 2 weeks after the intervention)
Investigators
Claudia P. Sanmiguel, MD
Health Sciences Assistant Professor
University of California, Los Angeles