Clinical trial NCT04420767: The Effect of Brain Stimulation (tDCS) in Food Cravings Control in Overweight/Obese Women
Official title: The Effect of Brain Neuromodulation on Food Cravings, Cognitive Control and Food Addiction Scales in Overweight/Obese Women Using tDCS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: food cravings
neuromodulation
brain
cognitive control
tDCS
prefrontal cortex
MRI
food addiction
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Yale Food Addiction Scale scores
timeFrame: Scores measured at baseline and at up-to 2 weeks after the intervention
measure: Change in Three-Factor Eating Questionnaire scores
timeFrame: Scores measured at baseline and at up-to 2 weeks after the intervention
Secondary outcomes:
measure: Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI)
timeFrame: Brain function at baseline and up-to 2 weeks after the intervention
measure: Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)
timeFrame: Brain MRS at baseline and up-to 2 weeks after the intervention
Other outcomes:
measure: Diet (3-day food intake record)
timeFrame: Values measured at baseline and at up-to 2 weeks after the intervention
measure: Change in Yale Food Addiction Scale scores at 3-months post-intervention
timeFrame: At 3-months after intervention
measure: Change in Three-Factor Eating Questionnaire scores at 3-months post-intervention
timeFrame: At 3-months after intervention
measure: Cognitive function assessment
timeFrame: Measured at baseline and up-to 2 weeks after the intervention
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Claudia P Sanmiguel, MD
role: PRINCIPAL_INVESTIGATOR
References: