NCT04420767

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2017

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

4.4 years

First QC Date

April 21, 2017

Last Update Submit

June 3, 2020

Conditions

Obesity

Keywords

food cravingsneuromodulationbraincognitive controltDCSprefrontal cortexMRIfood addiction

Outcome Measures

Primary Outcomes (2)

  • Change in Yale Food Addiction Scale scores

    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

    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 Outcomes (2)

  • Change in brain neural activity by functional Magnetic Resonance Imaging ( fMRI)

    Brain function at baseline and up-to 2 weeks after the intervention

  • Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)

    Brain MRS at baseline and up-to 2 weeks after the intervention

Other Outcomes (4)

  • Diet (3-day food intake record)

    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

    At 3-months after intervention

  • Change in Three-Factor Eating Questionnaire scores at 3-months post-intervention

    At 3-months after intervention

  • +1 more other outcomes

Study Arms (2)

tDCS and Go-No Go task

EXPERIMENTAL

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: tDCSBehavioral: Go-No GO task

Sham brain stimulation and Go-No Go task

SHAM COMPARATOR

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

Device: Sham brain stimulationBehavioral: Go-No GO task

Interventions

tDCSDEVICE

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

Also known as: Real brain stimulation
tDCS and Go-No Go task
Sham brain stimulationDEVICE

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

Sham brain stimulation and Go-No Go task
Go-No GO taskBEHAVIORAL

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 tasktDCS and Go-No Go task

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 28 and 40 kg/m2 high scores in the Yale-Food Addiction-Scale right-handed

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

ObesityFood Addiction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehaviorFeeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Claudia P Sanmiguel, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health Sciences Assistant Professor

Study Record Dates

First Submitted

April 21, 2017

First Posted

June 9, 2020

Study Start

January 4, 2017

Primary Completion

May 31, 2021

Study Completion

December 31, 2021

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations

US(1)