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

June 3, 2020 updated by: Claudia P. Sanmiguel, MD, University of California, Los Angeles

The Effect of Brain Neuromodulation on Food Cravings, Cognitive Control and Food Addiction Scales in Overweight/Obese Women Using tDCS

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Device: tDCS
Individuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex)
Other Names:
  • Real brain stimulation
Behavioral: 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)
SHAM_COMPARATOR: 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
Behavioral: 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)
Device: Sham brain stimulation
Individuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Scores measured at baseline and at up-to 2 weeks after the intervention
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).
Scores measured at baseline and at up-to 2 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI)
Time Frame: 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
Brain function at baseline and up-to 2 weeks after the intervention
Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)
Time Frame: 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
Brain MRS at baseline and up-to 2 weeks after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet (3-day food intake record)
Time Frame: Values measured at baseline and at up-to 2 weeks after the intervention
3-day food intake record: individuals will record everything they eat and drink for 3 days. To assess calorie intake and macro nutrients
Values measured at baseline and at up-to 2 weeks after the intervention
Change in Yale Food Addiction Scale scores at 3-months post-intervention
Time Frame: At 3-months after 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).
At 3-months after intervention
Change in Three-Factor Eating Questionnaire scores at 3-months post-intervention
Time Frame: At 3-months after 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).
At 3-months after intervention
Cognitive function assessment
Time Frame: Measured at baseline and up-to 2 weeks after the intervention
Multiple Abilities Self-Report Questionnaire (MASQ), a self-report measure comprising items from five cognitive domains; language, visuo-perceptual, verbal memory, visual memory, and attention. The maximum score for the whole scale is 190 points. Higher scores correlate with better function.
Measured at baseline and up-to 2 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Claudia P Sanmiguel, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 4, 2017

Primary Completion (ANTICIPATED)

May 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

June 3, 2020

First Posted (ACTUAL)

June 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 3, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#15-001929

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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