Neuromodulation targeted to the prefrontal cortex induces changes in energy intake and weight loss in obesity.
Marci E Gluck, Miguel Alonso-Alonso, Paolo Piaggi...
https://pubmed.ncbi.nlm.nih.gov/26530931Actively Recruiting
Phase 2
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID00739362
The Effects of Transcranial Direct Current Stimulation (TDCS) on Food Intake and Weight Loss
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-22
148
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether electrical stimulation of a brain area called the left dorsolateral prefrontal cortex (DLPFC), which influences feelings of fullness after eating, can affect food intake and weight loss in obese adults. The study also compares weight changes in people who attend weight loss counseling sessions to those who do not. This research focuses on adults aged 18 to 60 with obesity (BMI of 35 or higher) who do not have diabetes and are generally healthy. Participants stay at the NIH inpatient unit for the first 9 days, undergoing tests such as meal tests, blood and urine analyses, glucose tolerance tests, psychological assessments, and DEXA scans for body fat measurement. Some participants receive active transcranial direct current stimulation (tDCS) on the left DLPFC for 40 minutes, while others receive sham stimulation with little or no current. After discharge, participants follow a diet with 25% fewer calories at home for 4 weeks and visit the NIH unit three times weekly to receive either active or sham tDCS sessions. During the study, participants' food intake, weight change, brain activity measured by functional MRI, and hormone levels related to appetite are monitored. They also complete questionnaires on eating behaviors and stress. Follow-up visits occur at 6 months and 1 year to assess weight changes. The study lasts 9 weeks with outpatient visits three times per week and includes detailed safety monitoring and behavioral assessments throughout.
CONDITIONS
Brief Title
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Who Can Participate
Age: 18Years - 60Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) of 25 kg/m2 or higher
- Age between 18 and 60 years
- Right-handed
- Stable weight (within +/- 5%) for the last 3 months
- Generally healthy and non-diabetic
- Living in the Phoenix, AZ metropolitan area
You will not qualify if you...
- Weight over 300 pounds unless confirmed to fit MRI machine
- Use of metabolism or appetite-affecting medication in last 3 months
- Current pregnancy, recent pregnancy within 6 months, or lactation
- History of disorders affecting appetite or energy use (e.g., diabetes, Cushing's disease, thyroid disorders)
- Gastrointestinal diseases such as Crohn's disease, ulcerative colitis, celiac disease, or active gastric ulcer
- Unstable medical conditions like hepatitis, renal insufficiency, recent cancer treatment, or CNS disorders
- Alcohol abuse (AUDIT score 8 or higher)
- Drug use including amphetamines, cocaine, heroin, or marijuana
- Tobacco use exceeding very low dependence
- Postmenopausal women or symptoms of perimenopause
- Any contraindications for MRI (e.g., pacemaker, metal in skull, claustrophobia)
- Any other condition that may interfere with safety or study participation as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 9 weeks
Participants receive active or sham transcranial direct current stimulation (tDCS) to the left dorsolateral prefrontal cortex while following a reduced-calorie diet to support weight loss.
3 visits per week for 9 weeks
Follow-up
Duration - Up to 1 year after treatment
Participants return for weight measurements and assessments of behavioral and hormonal factors to monitor longer-term effects after treatment ends.
2 visits (at 6 months and 1 year post-treatment)
Trial Site Locations
Total: 1 location
1
NIDDK, Phoenix
Phoenix, Arizona, United States, 85014
Actively Recruiting
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Research Team
K
Kat A Ware
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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Published Research Related To This Trial
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.
Duc Son Nt Le, Nicola Pannacciulli, Kewei Chen...
https://pubmed.ncbi.nlm.nih.gov/17823419Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial.
Sascha Heinitz, Martin Reinhardt, Paolo Piaggi...
https://pubmed.ncbi.nlm.nih.gov/29046305Improved food Go/No-Go scores after transcranial direct current stimulation (tDCS) to prefrontal cortex in a randomized trial.
Emma J Stinson, Katherine T Travis, Greta Magerowski...
https://pubmed.ncbi.nlm.nih.gov/36052819