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Ultrasonic Treatment for Food Addiction

(USFADD Trial)

JK
Overseen ByJan Kubane, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Utah
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study will evaluate a new form of non-invasive deep brain therapy for food addiction. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled trial. The trial will evaluate brain target engagement using magnetic resonance imaging, Food Cravings Questionnaire-State, and changes in subject's weight over the course of the study.

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 data supports the effectiveness of the Ultrasonic Treatment for Food Addiction?

While there is no direct evidence for ultrasonic treatment, similar non-invasive brain stimulation techniques like transcranial direct current stimulation (tDCS) have shown promise in reducing food cravings and consumption in people with eating disorders and obesity. These techniques work by modulating brain activity, which may help control food-related behaviors.12345

How is Ultrasonic Treatment different from other treatments for food addiction?

Ultrasonic Treatment, or Low-Intensity Transcranial Focused Ultrasound Stimulation (LIFU), is unique because it uses sound waves to non-invasively target specific brain areas, potentially altering brain activity related to food cravings. Unlike other non-invasive brain stimulation methods like tDCS or rTMS, which use electrical or magnetic fields, LIFU uses focused ultrasound, which may offer more precise targeting of brain regions involved in food addiction.15678

Research Team

JAN KUBANEK - Home - Faculty Profile ...

Jan Kubanek, PhD

Principal Investigator

University of Utah

Eligibility Criteria

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
See 3 more

Timeline

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

Treatment Details

Interventions

  • Ultrasonic Treatment
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active stimulationActive Control1 Intervention
Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction
Group II: Sham stimulationPlacebo Group1 Intervention
Zero-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

Findings from Research

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

References

Clinical Utility of Add-On Transcranial Direct Current Stimulation for Binge Eating Disorder with Obesity in Schizophrenia. [2020]
Effects of transcranial direct current stimulation (tDCS) on binge eating disorder. [2022]
The critical role of cognitive-based trait differences in transcranial direct current stimulation (tDCS) suppression of food craving and eating in frank obesity. [2022]
Neuroimaging and neuromodulation approaches to study eating behavior and prevent and treat eating disorders and obesity. [2023]
Non-invasive brain stimulation for food cravings, consumption, and disorders of eating: A review of methods, findings and controversies. [2018]
Physical Therapy. [2018]
Invasive and Non-invasive Stimulation of the Obese Human Brain. [2020]
Long-Term Effects of Repeated Prefrontal Cortex Transcranial Direct Current Stimulation (tDCS) on Food Craving in Normal and Overweight Young Adults. [2018]