ObesityNCT04420767
The Effect of Brain Stimulation (tDCS) in Food Cravings Control in Overweight/Obese Women
A study testing tDCS and Go-No GO task in people with Obesity, run by University of California, Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- tDCS and Go-No GO task
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 28 and 40 kg/m2 high scores in the Yale-Food Addiction-Scale right-handed
Who cannot join
- 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.
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California
Los Angeles, California, 90095
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Real brain stimulation
Individuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex)
Sham brain stimulationDevice
Individuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex)
Go-No GO taskBehavioural
During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: tDCS; Behavioral: 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 Receives: Device: Sham brain stimulation; Behavioral: Go-No GO task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
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
Measured: Brain function at baseline and up-to 2 weeks after the intervention
Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)
Significant change in brain metabolites concentration at the prefrontal cortex (area involved in the inhibitory control of food intake) measured with Magnetic Resonance spectroscopy
Measured: Brain MRS at baseline and up-to 2 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start4 Jan 2017
- Primary completion31 May 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia P. Sanmiguel, MD, University of California, Los Angeles
- Investigators
- Claudia P Sanmiguel, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420767
- Sponsor's protocol ID
- IRB#15-001929
- Status last verified
- Jun 2020
- First submitted
- 21 Apr 2017
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brain Neuromodulation on Food Cravings, Cognitive Control and Food Addiction Scales in Overweight/Obese Women Using tDCS
- ClinicalTrials.gov ID
- NCT04420767
- Acronym / sponsor ID
- IRB#15-001929
- Conditions
- Obesity
- Keywords
- food cravings, neuromodulation, brain, cognitive control, tDCS, prefrontal cortex, MRI, food addiction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS and Go-No Go task | Experimental | Device: tDCS, Behavioral: Go-No GO taskCertain 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 |
| Sham brain stimulation and Go-No Go task | Sham comparator | Device: Sham brain stimulation, Behavioral: Go-No GO taskCertain 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI between 28 and 40 kg/m2 high scores in the Yale-Food Addiction-Scale right-handed
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: Real brain stimulationIndividuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex) | Device | tDCS and Go-No Go task |
| Sham brain stimulationIndividuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex) | Device | Sham brain stimulation and Go-No Go task |
| Go-No GO taskDuring the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go) | Behavioural | Sham brain stimulation and Go-No Go task, tDCS and Go-No Go task |
Primary outcome
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).
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).
2 secondary outcomes
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
Change in Brain metabolites concentrations by Magnetic Resonance Spectroscopy (MRS)
Time frame: Brain MRS at baseline and up-to 2 weeks after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia P Sanmiguel, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Go-No GO task in people with Obesity, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Yale Food Addiction Scale scores (time frame: Scores measured at baseline and at up-to 2 weeks after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020; AzTrials last refreshed its copy on 6 Nov 2026.