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 trial explores whether stimulating a part of the brain can help people feel fuller and lose weight. It uses electrical stimulation on the dorsolateral prefrontal cortex, a brain area linked to satiety, and tracks changes in eating habits and weight over four weeks. Participants will receive either real transcranial direct current stimulation (tDCS) or sham (fake) stimulation and may also attend weight loss counseling. The trial specifically seeks obese, non-diabetic individuals in Phoenix who haven't experienced major weight fluctuations or used appetite-affecting medications recently. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for treating obesity?

Research shows that transcranial direct current stimulation (tDCS) is generally safe. Past studies have used tDCS without problems to help reduce food cravings in individuals who are overweight or obese. Participants often experience a mild tingling under the electrodes, but serious side effects are rare. The procedure is non-invasive, meaning it doesn't involve surgery or inserting anything into the body.

More specifically, studies have found that tDCS can help control food cravings and improve mental well-being related to eating habits. While researchers are still determining the best way to use tDCS for obesity, current evidence supports its safety in clinical research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for obesity, which often include lifestyle modifications, medications, and surgery, Transcranial Direct Current Stimulation (TDCS) introduces a non-invasive brain stimulation technique. Researchers are excited about TDCS because it targets brain areas involved in appetite control and decision-making, potentially reducing the desire to overeat. This method offers a new mechanism of action compared to traditional approaches, aiming to influence neural activity directly. Additionally, TDCS is a painless, non-surgical option, which could make it more accessible and appealing for individuals seeking alternatives to conventional obesity treatments.

What evidence suggests that transcranial direct current stimulation (tDCS) might be an effective treatment for obesity?

Research has shown that Transcranial Direct Current Stimulation (tDCS), one of the treatments studied in this trial, can help reduce food cravings in people who are overweight or obese. Studies have found that tDCS, when applied to the prefrontal cortex (a brain area involved in self-control), can lessen the desire to eat. This treatment has also been linked to better control over food cravings and improved mental well-being related to eating habits. The stimulation appears to change how the brain responds to food signals, making it easier to avoid overeating. Overall, early findings suggest that tDCS could effectively manage obesity by reducing the urge to eat excessively. Participants in this trial may receive either active tDCS stimulation or a sham/no-stimulation as part of the study. ^{2 3 6 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9581736/

The effects of Transcranial Direct Current Stimulation on ... We included studies investigating the effects of tDCS on food craving in subjects affected by overweight and obesity. According to eligibility ...

2. psychiatryinvestigation.org psychiatryinvestigation.org/m/journal/view.php?number=1692

Efficacy of Transcranial Direct Current Stimulation for ... This study confirmed the beneficial effects of tDCS on food craving regulation in overweight or obese individuals and observed improved scores in psychological ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213158213000673

Impact of head fat and dose guidelines Recent studies show that acute neuromodulation of the prefrontal cortex with transcranial direct current stimulation (tDCS) can decrease food craving, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01030289

NCT01030289 | The Effectiveness of Transcranial Direct ... This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in decreasing food cravings.

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06234-8

Transcranial direct current stimulation to modulate brain ... This protocol describes a clinical trial that investigates the neurocognitive mechanisms of action for tDCS to modulate food cue-reactivity and cravings in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9003175/

Transcranial direct current stimulation to modulate brain ... The NeuroStim-Obesity trial is a prospective, randomized, sham-controlled, double-blind single-session tDCS trial targeting food craving in ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04218383

Transcranial Direct Current Stimulation for Impulsivity and ... In this study the investigators aim to assess whether transcranial direct current stimulation (tDCS; a safe non-invasive method for modulating the activity ...

8. journal.ppcr.org journal.ppcr.org/index.php/ppcrjournal/article/view/183

A systematic review on transcranial direct current stimulation ... Conclusions: This systematic review shows promising results regarding the use of tDCS in the treatment of obesity. However, the current ...