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

University of California, Los Angeles (UCLA)

Status: Unknown

Conditions: Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04420767

IRB#15-001929

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

tDCS and Go-No Go task

Experimental group

Description:

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

Treatment:

Behavioral: Go-No GO task

Device: tDCS

Sham brain stimulation and Go-No Go task

Sham Comparator group

Description:

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

Treatment:

Device: Sham brain stimulation

Behavioral: Go-No GO task