Brain Stimulation for Obesity

Recruiting at 1 trial location

Overseen By Kat A Ware

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Must not be taking: Metabolism drugs, Appetite drugs

Disqualifiers: Diabetes, Thyroid disorders, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

148 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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. 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.

Will I have to stop taking my current medications?

The trial requires that participants have not used medications affecting metabolism and appetite in the last three months. If you are currently taking such medications, you may need to stop them to be eligible for the study.

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, including those with obesity, as studies suggest that standard dosing guidelines can be applied without compromising safety. ^{1 2 3 4 5}

How does the brain stimulation treatment for obesity differ from other treatments?

This treatment uses transcranial direct current stimulation (tDCS), a noninvasive method that targets the brain's prefrontal cortex to help control eating behavior by modulating brain activity. Unlike traditional weight loss methods, tDCS aims to reduce food cravings and intake by enhancing cognitive control over eating, making it a novel approach for managing obesity. ^{1 4 5 6 7}

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for obesity?

Research suggests that tDCS, a brain stimulation technique, can help reduce food cravings and food intake by targeting specific brain areas involved in eating behavior. Studies have shown that tDCS can lead to weight loss and decreased energy intake in people with obesity by modifying brain activity, particularly in the prefrontal cortex, which is linked to self-control and decision-making. ^{1 2 3 7 8}

Who Is on the Research Team?

Marci E Gluck, Ph.D.

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Are You a Good Fit for This Trial?

This trial is for non-diabetic, right-handed adults aged 18-60 living in Phoenix, AZ with obesity (BMI ≥ 25 kg/m² and weight <350 lbs). Participants should have had a stable weight for the last three months. Exclusions include postmenopausal women, those with conditions affecting appetite or metabolism, recent medication use that affects metabolism/appetite, substance abuse issues, unstable medical conditions, contraindications for MRI scans or any other condition deemed unsafe by the investigator.

Inclusion Criteria

You must be right-handed because the treatment targets a specific part of the brain that has only been studied in right-handed individuals.

You must be right-handed because the treatment is specifically designed for the left side of the brain, and the evidence supporting its effectiveness is based on right-handed individuals.

My BMI is 25 or higher.

Exclusion Criteria

I am a postmenopausal woman or experiencing symptoms of perimenopause.

Any conditions contraindicated for MRI (e.g., pacemaker, metal in the cranial cavity, significant claustrophobia, holes in the skull made by trauma or surgery)

Weight > 300 lbs (136 kg), as this is the weight limit of the fMRI machine

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Evaluation

Participants are admitted to the NIH inpatient unit for tests including meal tests, blood and urine tests, glucose tolerance test, weight measurement, psychological assessments, and DEXA scan

9 days

Inpatient stay

Treatment

Participants receive either real or sham transcranial direct current stimulation (tDCS) while following a reduced-calorie diet

4 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for weight changes and other outcomes

9 weeks

3 visits per week (in-person)

Long-term Follow-up

Participants return for weight measurements and assessments

1 year

2 visits (6 months and 1 year)

What Are the Treatments Tested in This Trial?

Interventions

• Sham/no-stimulation
• Transcranial Direct Current Stimulation (TDCS)

Trial Overview The study tests if brain stimulation of the dorsolateral prefrontal cortex influences food intake and assists in weight loss over four weeks. It involves initial inpatient testing followed by outpatient visits where participants receive either real transcranial direct current stimulation (TDCS) or sham treatment while maintaining a reduced-calorie diet.

How Is the Trial Designed?

Group I: 2-Active Active Control 1 Intervention

Active tDCS stimulation

Group II: 3-Active Active Control 1 Intervention

Active tDCS stimulation

Group III: 3-Sham Placebo Group 1 Intervention

Sham/no-stimulation

Group IV: 1-Sham Placebo Group 1 Intervention

Active tDCS stimulation

Group V: 2-Sham Placebo Group 1 Intervention

Sham/no-stimulation

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study involving 9 healthy volunteers with obesity, anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (LDLPFC) led to a significant reduction in energy intake and greater weight loss compared to cathodal tDCS.

The findings suggest that stimulating the LDLPFC with anodal tDCS may enhance control over eating behaviors, indicating a potential new approach for weight management in individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation targeted to the prefrontal cortex induces changes in energy intake and weight loss in obesity. Gluck, ME., Alonso-Alonso, M., Piaggi, P., et al.[2019]

Transcranial direct current stimulation (tDCS) shows potential for reducing food cravings by modulating brain activity, particularly in the dorsolateral prefrontal cortex, based on findings from three small clinical trials.

Despite promising results in decreasing cravings, the application of tDCS for treating obesity is still largely unexplored, highlighting the need for further research to understand its mechanisms and effectiveness in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating tDCS into the field of obesity: mechanism-driven approaches. Alonso-Alonso, M.[2021]

Transcranial direct current stimulation (tDCS) can effectively modulate brain activity related to food cravings and intake, showing promise for obesity treatment.

The study found that while subcutaneous fat affects current density during tDCS, the standard dosing parameters for tDCS used in the general population are still appropriate for obese individuals, ensuring both efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computational modeling of transcranial direct current stimulation (tDCS) in obesity: Impact of head fat and dose guidelines. Truong, DQ., Magerowski, G., Blackburn, GL., et al.[2021]

This study is the first to demonstrate that transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex can significantly reduce food craving and consumption in adults with frank obesity, particularly when considering individual traits like impulsiveness.

The results indicate that tDCS may be more effective for certain individuals, such as females with lower attention-type impulsiveness and males with specific calorie restriction intentions, highlighting the need to account for cognitive differences in future obesity treatment studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The critical role of cognitive-based trait differences in transcranial direct current stimulation (tDCS) suppression of food craving and eating in frank obesity. Ray, MK., Sylvester, MD., Osborn, L., et al.[2022]

Transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC) has shown promising effects in reducing food cravings in individuals with overweight and obesity, based on a systematic review of 5 studies.

While tDCS appears to be beneficial, results were mixed for other stimulation methods, indicating the need for further research with larger sample sizes and better controls to confirm its efficacy as part of a comprehensive approach to managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Transcranial Direct Current Stimulation on food craving and food intake in individuals affected by obesity and overweight: a mini review of the magnitude of the effects. Orrù, G., Cesari, V., Malloggi, E., et al.[2022]

Transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (DLPFC) did not effectively reduce food craving or consumption compared to stimulation of the sensorimotor cortex (SMC), suggesting that this method may not be a viable treatment for obesity.

Despite 71% of participants being unable to distinguish between the real and control conditions, the lack of efficacy raises questions about the role of tDCS in appetite regulation and highlights the need for better control methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcranial direct current stimulation (tDCS) on food craving and eating when using a control method that minimizes guessing of the real vs. control condition. Stevens, CE., Lausen, MA., Wagstaff, LE., et al.[2021]

In a study involving 23 individuals with obesity, short-term anodal tDCS targeting the left dorsolateral prefrontal cortex did not lead to immediate changes in food intake or weight compared to sham stimulation.

However, after 15 sessions of anodal tDCS, participants reported significantly lower hunger and reduced snack food intake, suggesting that longer-term stimulation may help in managing appetite in individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial. Heinitz, S., Reinhardt, M., Piaggi, P., et al.[2023]

The NeuroStim-Obesity trial is investigating the effects of transcranial direct current stimulation (tDCS) on food cravings in 64 adults with obesity or overweight, aiming to understand how it can modulate brain responses to food cues.

The primary outcome is to measure changes in neural responses in the ventral striatum after tDCS, which could lead to personalized interventions for obesity by identifying predictive biomarkers for treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation to modulate brain reactivity to food cues in overweight and obese adults: study protocol for a randomized controlled trial with fMRI (NeuroStim-Obesity). Ghobadi-Azbari, P., Malmir, N., Vartanian, M., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation targeted to the prefrontal cortex induces changes in energy intake and weight loss in obesity. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Translating tDCS into the field of obesity: mechanism-driven approaches. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Computational modeling of transcranial direct current stimulation (tDCS) in obesity: Impact of head fat and dose guidelines. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The critical role of cognitive-based trait differences in transcranial direct current stimulation (tDCS) suppression of food craving and eating in frank obesity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The effects of Transcranial Direct Current Stimulation on food craving and food intake in individuals affected by obesity and overweight: a mini review of the magnitude of the effects. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Effect of transcranial direct current stimulation (tDCS) on food craving and eating when using a control method that minimizes guessing of the real vs. control condition. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation directed at the prefrontal cortex of subjects with obesity reduces snack food intake and hunger in a randomized trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation to modulate brain reactivity to food cues in overweight and obese adults: study protocol for a randomized controlled trial with fMRI (NeuroStim-Obesity). [2022]