Neurofeedback for Obesity

Overseen By Kathleen A Garrison, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Anti-obesity medications

Disqualifiers: Nicotine, Neurological, Psychiatric, Diabetes, others

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

Compensation: Varies

Number of Visits: 4

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether individuals with a high craving for food and obesity can alter their brain's response to food cues through neurofeedback. Neurofeedback is a technique that shows how the brain responds to certain stimuli and helps individuals learn to control it. Participants in this study will undergo sessions using Craving Network Neurofeedback, receiving either real or sham (fake) feedback, to determine its effect on cravings and eating habits. Individuals who have struggled with obesity, have a BMI over 25, and frequently crave food might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on obesity and cravings.

Will I have to stop taking my current medications?

The trial requires that you do not use anti-obesity medications. If you are taking these, you would need to stop before participating.

What prior data suggests that this neurofeedback technique is safe for individuals with obesity?

Research on neurofeedback, including studies on eating habits and obesity, suggests it is generally safe. Participants in these studies did not report any serious side effects. For example, one study found that people using neurofeedback experienced a significant decrease in binge eating episodes, with no major safety concerns.

Another study tested infraslow neurofeedback, a similar method, and participants did not report any severe unwanted effects.

Although this trial is labeled as "Not Applicable" for its phase, existing research on neurofeedback for obesity provides insight into its safety. It appears well-tolerated by participants, with no major safety issues reported in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Craving Network Neurofeedback for obesity because it offers a novel approach by using real-time brain imaging to help individuals regulate their cravings. Unlike traditional treatments such as diet, exercise, or medication, this method involves participants seeing their brain activity through fMRI and learning to control areas associated with cravings. This technique could empower individuals to directly influence their brain's response to food cues, potentially leading to more sustainable weight management.

What evidence suggests that neurofeedback is effective for obesity?

This trial will compare Craving Network Neurofeedback with a control neurofeedback approach. Studies have shown that neurofeedback training can help people with obesity make healthier food choices by strengthening the connection between brain areas involved in cravings. One study found that neurofeedback sessions led to significant weight loss and better self-control, with participants also improving their eating habits. These findings suggest that neurofeedback could be a promising tool for managing obesity by changing how the brain responds to food signals. ^{1 2 3 4 6}

Who Is on the Research Team?

Kathleen A Garrison, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 60 who are overweight or obese, with a body mass index (BMI) over 25 and experience strong food cravings as indicated by scoring more than 2.37 on the Food Craving Inventory.

Inclusion Criteria

My food craving score is above 2.37.

My BMI is over 25.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurofeedback Treatment

Participants undergo three imaging (fMRI) sessions of experimental or sham neurofeedback

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in craving network strength and eating behavior

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Craving Network Neurofeedback

Trial Overview The study is examining if people with high food cravings can use neurofeedback to alter their brain's response to food cues, which may affect their desire for food and eating habits.

How Is the Trial Designed?

Group I: Neurofeedback Experimental Treatment 1 Intervention

Three imaging (fMRI) sessions of experimental feedback.

Group II: Control neurofeedback Placebo Group 1 Intervention

Three imaging (fMRI) sessions of sham feedback.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study involving 21 obese women with food addiction symptoms, infraslow neurofeedback (ISF-NF) significantly increased brain activity in the posterior cingulate cortex (PCC) and reduced food craving after six sessions over three weeks, with no reported adverse effects.

The results indicate that ISF-NF may be a promising therapeutic approach for managing food cravings in individuals with obesity, as it led to measurable changes in brain activity and a decrease in craving levels compared to a placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised, double-blind, placebo-controlled parallel trial of closed-loop infraslow brain training in food addiction. Leong, SL., Vanneste, S., Lim, J., et al.[2023]

In a pilot study of 34 overweight and obese children, neurofeedback training did not lead to greater weight loss compared to standard lifestyle recommendations, with the intervention group showing a smaller reduction in body mass index after 6 months.

Despite less weight loss, children receiving neurofeedback reported improvements in eating behaviors, attention, hyperactivity, and sleep patterns, suggesting potential benefits beyond weight management that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of neurofeedback training in childhood obesity management: a pilot study. Chirita-Emandi, A., Puiu, M.[2015]

A systematic review of 13 studies suggests that biofeedback and neurofeedback techniques may be beneficial in treating dysfunctional eating behaviors, such as food cravings and rumination, although they have not shown significant effects on body image disturbance.

These feedback-based techniques appear to modify both the body's sympathetic response to food-related stimuli and brain activity in reward-related areas, indicating a potential mechanism for their effectiveness in addressing certain eating disorder symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feedback-Based Treatments for Eating Disorders and Related Symptoms: A Systematic Review of the Literature. Imperatori, C., Mancini, M., Della Marca, G., et al.[2019]

A randomized controlled trial involving 27 female restrained eaters showed that a cue exposure-based EEG neurofeedback treatment significantly reduced weekly overeating episodes and related distress compared to a waiting list control group.

The positive effects of the neurofeedback treatment were maintained at a 3-month follow-up, and participants also reported improved dieting success and reduced food cravings, indicating potential long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback reduces overeating episodes in female restrained eaters: a randomized controlled pilot-study. Schmidt, J., Martin, A.[2019]

In a study involving eight overweight or obese men, real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback training successfully enhanced the functional connectivity between the dorsolateral prefrontal cortex (dlPFC) and ventromedial prefrontal cortex (vmPFC), which are crucial for self-control and reward processing.

Although participants showed a trend towards making healthier food choices after the training, there was also a trend of increased snack intake, suggesting that while neurofeedback may help with self-control, it may not immediately translate to reduced calorie consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volitional regulation of brain responses to food stimuli in overweight and obese subjects: A real-time fMRI feedback study. Spetter, MS., Malekshahi, R., Birbaumer, N., et al.[2018]

In a study involving 38 overweight or obese participants, a single session of fMRI neurofeedback training successfully increased activity in the left dorsolateral prefrontal cortex (dlPFC), which is linked to better control over eating behaviors.

Both the dlPFC and control groups reported decreased palatability and choice for high-calorie foods after training, suggesting that neurofeedback may enhance self-control mechanisms related to food intake, although actual snack consumption did not change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time fMRI neurofeedback training to improve eating behavior by self-regulation of the dorsolateral prefrontal cortex: A randomized controlled trial in overweight and obese subjects. Kohl, SH., Veit, R., Spetter, MS., et al.[2019]

In a proof-of-concept study with 10 healthy females, motivational neurofeedback successfully helped participants down-regulate brain activation in response to food cues, indicating potential for modifying cravings.

Preliminary results suggest that this neurofeedback approach not only decreased activation in key motivational brain areas but also correlated with a reduction in hunger, highlighting its potential as a behavioral intervention for managing appetitive responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback of visual food cue reactivity: a potential avenue to alter incentive sensitization and craving. Ihssen, N., Sokunbi, MO., Lawrence, AD., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-overweight-6-2024-27fba

Neurofeedback for Obesity Research shows that neurofeedback training can help people with obesity improve self-control over food choices by increasing the connection between brain areas ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06426693?spons=NIDDK&aggFilters=status:rec&viewType=Table&rank=9

NCT06426693 | Craving Network Neurofeedback Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...

3. trialx.com trialx.com/clinical-trials/listings/306496/craving-network-neurofeedback/

Craving Network Neurofeedback | Clinical Research Trial ... This project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12565648/

Evaluating the Efficacy of Neurofeedback in Post-Bariatric ... Significant reductions were also found in BUT subscales including Weight Phobia (p = 0.041, d = 0.84), Body Image Concern (p = 0.039, d = 0.90), ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0261561418300438

A pilot study of a novel therapeutic approach to obesity neurofeedback sessions produced a statistically significant weight loss, a trend of behavioral improvement in external eating and self-control and enhanced ...

6. nature.com nature.com/articles/s41598-018-30181-7

A randomised, double-blind, placebo-controlled parallel ... This randomised, double-blind, placebo-controlled parallel study explored the potential therapeutic effects of infraslow neurofeedback (ISF-NF) on food craving.