Ultrasonic Treatment for Food Addiction

(USFADD Trial)

Overseen By Jan Kubane, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Utah

Disqualifiers: Serious suicide attempt, MRI intolerance, Pregnant, Diabetic, others

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

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, non-invasive brain therapy called Ultrasonic Treatment to assist individuals with food addiction. The therapy uses low-intensity ultrasound waves to target specific brain areas linked to food cravings. The study will compare the real treatment to a sham (fake) version to evaluate the ultrasound's effectiveness in reducing cravings and aiding weight loss. Candidates may qualify if they have struggled with weight loss and have a body mass index (BMI) of 30 or more, or 25 with conditions like high blood pressure or sleep apnea. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants the chance to be among the first to benefit from this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that this ultrasonic treatment is safe for food addiction?

Research has shown that low-intensity focused ultrasound (LIFU) is generally safe. Studies have found that, when used correctly, LIFU is well-tolerated and poses little risk. This ultrasound treatment has been tested in various conditions, such as brain and mental health disorders, and has consistently proven safe in these areas.

Although specific data from trials on food addiction is not yet available, existing evidence from other studies suggests that this treatment is generally safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for food addiction focus on behavioral therapy or medications that alter brain chemistry. But this new ultrasonic treatment works differently, targeting deep brain regions associated with cravings and impulse control using low-intensity focused ultrasound. Researchers are excited because this non-invasive method could potentially modulate brain activity without the side effects associated with medication. Plus, it offers a novel approach by directly influencing brain circuits involved in addiction, which could lead to faster and more lasting changes in behavior.

What evidence suggests that this ultrasonic treatment is effective for food addiction?

This trial will compare active ultrasonic treatment with sham stimulation for food addiction. Research has shown that low-intensity transcranial focused ultrasound (LITUS) can alter brain function. This technique holds promise for treating brain and mental health issues, suggesting potential benefits for food addiction as well. Studies have found LITUS effective in treating conditions like mental health disorders and high blood pressure by safely modifying brain activity. Although specific data on food addiction is limited, LITUS's success in related areas suggests it could be worth exploring for this issue. ^{1 2 3 4 5}

Who Is on the Research Team?

Jan Kubanek, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for individuals who struggle with compulsive eating and obesity, having a BMI of at least 30 kg/m^2, or at least 25 kg/m^2 with related health issues like high blood pressure. Participants should have tried to lose weight through dieting without success.

Inclusion Criteria

History of at least one self-reported unsuccessful dietary effort to lose body weight

My BMI is 30 or higher, or it's 25 or higher with a condition like high blood pressure.

Exclusion Criteria

Lifetime history of a serious suicide attempt

MRI intolerance or contraindication

Pregnant or breast feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-intensity transcranial focused ultrasound stimulation or sham stimulation for food addiction

16 weeks

16 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasonic Treatment

Trial Overview The study tests a non-invasive brain therapy using ultrasonic waves aimed at treating food addiction. It involves comparing active ultrasonic stimulation against sham (fake) treatment to see if it affects cravings and weight loss, monitored by MRI scans and questionnaires.

How Is the Trial Designed?

Group I: Active stimulation Active Control 1 Intervention

Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction

Group II: Sham stimulation Placebo Group 1 Intervention

Zero-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Neuroimaging studies have identified brain anomalies in individuals with obesity and eating disorders, revealing decreased metabolism in key brain areas and heightened activation in reward regions, which may lead to increased food cravings and potential weight gain.

Non-invasive neuromodulation techniques, such as real-time fMRI neurofeedback and repetitive transcranial magnetic stimulation (rTMS), show promise in altering brain processes related to eating behavior, potentially offering new therapeutic strategies for treating obesity and eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroimaging and neuromodulation approaches to study eating behavior and prevent and treat eating disorders and obesity. Val-Laillet, D., Aarts, E., Weber, B., et al.[2023]

Non-invasive brain stimulation (NIBS), especially repetitive transcranial magnetic stimulation (rTMS), has been shown to effectively reduce food cravings in both single-session and multi-session formats, with more consistent results compared to transcranial direct current stimulation (tDCS).

While preliminary findings suggest potential benefits of NIBS for treating obesity and eating disorders, more research is needed to confirm these effects, particularly for conditions like bulimia and binge eating disorder, and caution is advised when considering NIBS for anorexia due to possible adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive brain stimulation for food cravings, consumption, and disorders of eating: A review of methods, findings and controversies. Hall, PA., Vincent, CM., Burhan, AM.[2018]

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]

Neuromodulation techniques like transcranial direct current stimulation (tDCS), repetitive transcranial magnetic stimulation (rTMS), and deep brain stimulation (DBS) are increasingly recognized for their effectiveness in treating addiction-related issues.

In addition to neuromodulation, traditional physical therapy methods such as biofeedback, physical activity, and acupuncture also play a significant role in addressing both the physical and psychological aspects of addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapy. Xiao, LJ., Tao, R.[2018]

Transcranial direct-current stimulation (tDCS) is a safe and well-tolerated noninvasive brain stimulation technique that can modify eating behaviors.

In a case report, tDCS was successfully used as an add-on treatment for a patient with schizophrenia, effectively reducing food cravings and helping to reverse weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utility of Add-On Transcranial Direct Current Stimulation for Binge Eating Disorder with Obesity in Schizophrenia. Sreeraj, VS., Masali, M., Shivakumar, V., et al.[2020]

Transcranial direct current stimulation (tDCS) significantly reduced cravings for various foods and decreased overall food intake by 11% and preferred food intake by 17.5% in individuals with binge eating disorder (BED), based on a study of 30 adults.

The study suggests that tDCS may enhance cognitive control and reduce the desire for food rewards, indicating its potential as a safe and noninvasive treatment option for BED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation (tDCS) on binge eating disorder. Burgess, EE., Sylvester, MD., Morse, KE., et al.[2022]

Non-invasive brain stimulation techniques like transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) can potentially reduce food cravings and calorie intake by modulating activity in the dorsolateral prefrontal cortex, which is linked to executive functioning and reward processing.

Invasive vagal nerve stimulation (VNS) has been approved by the FDA for obesity treatment, as it may help reduce appetite by signaling the brain's homeostatic demands, but more large-scale clinical trials are needed to confirm the efficacy of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Invasive and Non-invasive Stimulation of the Obese Human Brain. Pleger, B.[2020]

Repeated transcranial direct current stimulation (tDCS) of the right dorsolateral prefrontal cortex (DLPFC) significantly reduces both current and habitual food cravings in healthy adults, with effects lasting up to 30 days after treatment.

Active tDCS was particularly effective in decreasing cravings for fast food and sweets, suggesting its potential as a therapeutic intervention for managing food intake and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Effects of Repeated Prefrontal Cortex Transcranial Direct Current Stimulation (tDCS) on Food Craving in Normal and Overweight Young Adults. Ljubisavljevic, M., Maxood, K., Bjekic, J., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924006627

A Comprehensive Review of Low-Intensity Focused ... In this study, we provide a review of the most recent LIFU literature covering three key domains: 1) the history of focused ultrasound technology, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11612502/

The therapeutic potential of low-intensity focused ultrasound ... LIFU is a promising modality for precise and invasive modulation of brain activity, capable of redefining the landscape of SUD treatment.

3. withpower.com withpower.com/trial/ultrasonic-treatment-for-food-addiction-a8d5b

Ultrasonic Treatment for Food Addiction (USFADD Trial) This study will evaluate a new form of non-invasive deep brain therapy for food addiction. Low-intensity transcranial focused ultrasound stimulation will ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700779/

A Comprehensive Review of Low-Intensity Focused ... In this study, we provide a review of the most recent LIFU literature covering three key domains: 1) the history of focused ultrasound ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763423004700

The effectiveness and safety of low-intensity transcranial ... LITUS demonstrated therapeutic efficacy in neurological disorders, psychiatric disorders, pain, sleep disorders and hypertension.