AzTrials
AzTrials

Electric Stimulation TherapyPhase 2NCT00739362

Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment

A Phase 2 study testing Transcranial Direct Current Stimulation (TDCS) in people with Electric Stimulation Therapy and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study will determine whether electrical stimulation of an area of the brain called the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Electric Stimulation Therapy, Obesity, Weight Loss
What is being tested?
Transcranial Direct Current Stimulation (TDCS)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
1 siteUnited States
Study dates
19 Jan 2009to 31 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI >= 25 kg/m^2
  • Age 18-60 years. Women who are post-menopausal will be excluded from the study due to changes in their metabolism that could affect weight loss. We will set the cutoff at age 60 so that the age difference between the men and women is not too great for analysis purposes. Minors under the age of 18 will be excluded because the time requirements of the study are such that they would interfere with school schedules.
  • Right-handedness (because the treatment will be given to the left dorsolateral prefrontal cortex and the evidence accumulated in this region was only in right-handed individuals).
  • Weight stable (+/- 5 percent) for last 3 months as determined by volunteer report.

Who cannot join

  • Weight > 300 lbs (136 kg), as this is the general size limit of the fMRI machine. Participants >300 pounds may be included if their body habitus will allow them to fit within the diameter of the MRI machine. This will be determined on a case-by-case basis after consultation with staff at Banner Health Neuroimaging Center.
  • Use of medication affecting metabolism and appetite in the last three months
  • Current pregnancy, pregnancy within the past 6 months or currently lactating
  • History or clinical manifestations of acute or chronic disorders or conditions that may affect appetite or energy expenditure (such as, but not limited to type 1 or type 2 diabetes, Cushing s disease, thyroid disorders, coccidiomycoses)
  • Gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism
  • Current, unstable medical conditions such as hepatitis, renal insufficiency, cancer requiring treatment in the last 5 years, or central nervous system disorders etc. as assessed by history and physical exam
Show all 12Show fewer
  • Evidence of alcohol abuse as defined by >= 8 point score on the Alcohol consumption screening AUDIT questionnaire in adults
  • Evidence of drug use such as amphetamines, cocaine, heroin, or marijuana
  • Current use of tobacco products that exceed "Very Low Dependence" on the Fagerstr(SqrRoot)(Delta)m Test for Nicotine Dependence Tool (score greater than 2)
  • Postmenopausal women or symptoms of perimenopause (e.g. hot flashes, onset of irregular periods following age 40, elevation of FSH >20 IU following age 40 years)
  • Any conditions contraindicated for MRI (e.g., pacemaker, metal in the cranial cavity, significant claustrophobia, holes in the skull made by trauma or surgery)
  • Any condition not specifically mentioned above that, in the opinion of the investigator, may interfere with the study or prove unsafe for participation.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NIDDK, Phoenix

    Phoenix, Arizona, 85004

Other trials in United States

About this study

Official title: The Effects of Transcranial Direct Current Stimulation (TDCS) on Food Intake and Weight Loss

This study will determine whether electrical stimulation of an area of the brain called the dorsolateral prefrontal cortex, which is important in determining the feeling of fullness after eating, affects how much food a person eats and weight loss over 4 weeks. It will also compare weight changes in people who attend weight loss counseling sessions and those who do not over this period of time.

Obese, non-diabetic people between 18 and 60 years of age who are in good health and who live in the Phoenix, AZ, metropolitan area are eligible for this study. Candidates must have a body mass index of 35 kg/m(2) or more and weigh less than 350 pounds.

Read more

Participants are admitted to the NIH inpatient unit in Phoenix for the first 9 days of the study for tests, which include meal tests to determine eating behaviors and caloric intake, blood and urine tests, glucose tolerance test, weight measurement, psychological assessments and DEXA scan to measure body fat. For 3 of the days, they will be asked to eat all of their food from automated vending machines. Some subjects receive transcranial direct current stimulation (TDCS). For this procedure, electrodes that conduct electricity are placed on the head and arm and the current is turned on for 40 minutes. Some tingling may be felt under the electrodes. Other subjects receive sham TDCS, with the current turned on only very briefly.

After the evaluations, subjects are discharged home from the NIH unit and instructed to eat 25 percent fewer calories than they consumed while on a weight maintenance diet the first 3 days of their inpatient stay. They maintain the lower calorie diet at home for 4 weeks. During this period they come to the NIH unit 3 days a week to receive either real or sham TDCS.

...

Read the detailed description

In our studies of brain function examining areas related to hunger and fullness, a part of the brain called the left dorsolateral prefrontal cortex (DLPFC) was found to be less active in obese versus lean individuals following a meal. Furthermore, in women who have lost and maintained weight loss, the activity in this area following a meal is similar to that of lean women, suggesting that the activity in this area may improve with weight loss. Two recent studies have demonstrated a lack of increase in food craving following non-invasive brain stimulation to the left DLPFC when compared to a sham control group that did not receive brain stimulation.

The aim of our protocol is to investigate the effectiveness of one type of noninvasive brain stimulation technique, transcranial direct current stimulation (tDCS) on food intake in significantly overweight (BMI >= 30 kg/m^2) individuals. In study 1, we enrolled individuals who previously participated in this study and examined how anodal (active) stimulation or sham (no stimulation) to the left DLPFC compared to their previous stimulation condition in terms of both weight loss and food intake. The aim of Study 2 was to compare active versus sham anodal left DLPFC stimulation in a new group of volunteers.

Study 3 will be a 9-week double-blind parallel outpatient study where volunteers will come to the Clinical Research Unit 3x per week and be randomized to receive either active tDCS or "no stimulation" (sham) to the left DLPFC for stimulation sessions while being asked to follow diet that is a 25% reduction from their calculated weight maintenance calories. The primary outcome measurement will be total food (kcal) intake during a snack food taste test and weight change. Volunteers will also undergo 4 sessions of brain imaging (called functional MRI) to help us understand how the stimulation is working. Participants will also be asked to come back to the Unit after 6 months and 1 year for weight measurements. We will also examine appetitive hormones, neurocognitive and behavioral factors, which might also mediate potential changes in food intake and weight following tDCS to the left DLPFC. Positive findings from this study could demonstrate the utility of a novel and safe treatment for severe obesity. Future studies could include longer clinical trials of tDCS with extended follow-up durations.

Being tested
Transcranial Direct Current Stimulation (TDCS), Sham/no-stimulation
Keywords
Behavioral Weight Loss Treatment, Obesity, Appetite Control, Weight Loss, Transcranial Direct Current Stimulation (TDCS)
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Direct Current Stimulation (TDCS)Device

    Active tDCS (anodal left DLPFC)

  • Sham/no-stimulationOther

    Sham tDCS

Study groups in NCT00739362
Study groupRoleWhat they receive
1-ShamSham comparatorActive tDCS stimulation
Receives: Device: Transcranial Direct Current Stimulation (TDCS)
2-ActiveActive comparatorActive tDCS stimulation
Receives: Device: Transcranial Direct Current Stimulation (TDCS)
2-ShamSham comparatorSham/no-stimulation
Receives: Other: Sham/no-stimulation
3-ActiveActive comparatorActive tDCS stimulation
Receives: Device: Transcranial Direct Current Stimulation (TDCS)
3-ShamSham comparatorSham/no-stimulation
Receives: Other: Sham/no-stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. weight loss

    Weight (kg)

    Measured: Baseline, week 9

  2. food intake

    Total energy intake during snack food taste test

    Measured: Baseline, week 9

  3. brain fMRI activation in the left DLPFC when shown food vs. nonfood visual cues

    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues

    Measured: Weeks 1 and 9

Secondary outcomes (11)
  1. weight loss

    weight (kg)

    Measured: Baseline, 6 months

  2. responses to Iowa Gambling Task

    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

    Measured: Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood

  3. responses to Three Factor Eating Questionnaire

    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

    Measured: Baseline, week 9

  4. responses to MacArthur Scale of Subjective Social Status

    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

    Measured: Baseline, week 9

  5. responses to Gormally Binge Eating Questionnaire

    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

    Measured: Baseline, week 9

  6. weight loss

    weight (kg)

    Measured: Baseline, 1 year

  7. responses to Perceived Stress Scale

    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

    Measured: Baseline, week 9

  8. GLP-1

    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood

    Measured: Weeks 1 and 9

  9. responses to Go/No Go Task

    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, performance on questionnaires

    Measured: Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood

  10. Ghrelin

    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, appetitive hormone levels measured in blood

    Measured: Weeks 1 and 9

  11. macronutrient preferences

    Percent signal change in the left DLPFC when shown food vs. nonfood visual cues, macronutrient preferences determined during snack food taste test

    Measured: Baseline, week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2008 (estimated)
  2. Study start19 Jan 2009
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00739362
Sponsor's protocol ID
999908191
Other IDs
08-DK-N191
Status last verified
28 Aug 2026
First submitted
20 Aug 2008
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gluck ME, Alonso-Alonso M, Piaggi P, Weise CM, Jumpertz-von Schwartzenberg R, Reinhardt M, Wassermann EM, Venti CA, Votruba SB, Krakoff J. Neuromodulation targeted to the prefrontal cortex induces changes in energy intake and weight loss in obesity. Obesity (Silver Spring). 2015 Nov;23(11):2149-56. doi: 10.1002/oby.21313.

    PubMed 26530931
  • Le DS, Pannacciulli N, Chen K, Salbe AD, Del Parigi A, Hill JO, Wing RR, Reiman EM, Krakoff J. Less activation in the left dorsolateral prefrontal cortex in the reanalysis of the response to a meal in obese than in lean women and its association with successful weight loss. Am J Clin Nutr. 2007 Sep;86(3):573-9. doi: 10.1093/ajcn/86.3.573.

    PubMed 17823419
  • Heinitz S, Reinhardt M, Piaggi P, Weise CM, Diaz E, Stinson EJ, Venti C, Votruba SB, Wassermann EM, Alonso-Alonso M, Krakoff J, Gluck ME. Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial. Am J Clin Nutr. 2017 Dec;106(6):1347-1357. doi: 10.3945/ajcn.117.158089. Epub 2017 Oct 18.

    PubMed 29046305
  • Stinson EJ, Travis KT, Magerowski G, Alonso-Alonso M, Krakoff J, Gluck ME. Improved food Go/No-Go scores after transcranial direct current stimulation (tDCS) to prefrontal cortex in a randomized trial. Obesity (Silver Spring). 2022 Oct;30(10):2005-2013. doi: 10.1002/oby.23529. Epub 2022 Sep 2.

    PubMed 36052819

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transcranial Direct Current Stimulation (TDCS) in people with Electric Stimulation Therapy and Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

weight loss (time frame: Baseline, week 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00739362, which also lists 4 linked publications.

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 5 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in