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

NCT ID: NCT04420767

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-04

Study Completion Date

2021-12-31

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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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tDCS and 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

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

Individuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex)

Go-No GO task

Intervention Type BEHAVIORAL

During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go)

Sham brain stimulation and 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

Group Type SHAM_COMPARATOR

Sham brain stimulation

Intervention Type DEVICE

Individuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex)

Go-No GO task

Intervention Type BEHAVIORAL

During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go)

Interventions

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tDCS

Individuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex)

Intervention Type DEVICE

Sham brain stimulation

Individuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex)

Intervention Type DEVICE

Go-No GO task

During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go)

Intervention Type BEHAVIORAL

Other Intervention Names

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Real brain stimulation

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Claudia P. Sanmiguel, MD

Health Sciences Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia P Sanmiguel, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University of California

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB#15-001929

Identifier Type: -

Identifier Source: org_study_id

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