Ultrasonic Treatment for Food Addiction

(USFADD Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Jan Kubanek, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of Utah

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

No Placebo Group

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

Research Team

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

Trial 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 (Procedure)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Utah Salt Lake City, UT

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Findings from Research

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]

References

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

Clinical Utility of Add-On Transcranial Direct Current Stimulation for Binge Eating Disorder with Obesity in Schizophrenia. [2020]

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

Effects of transcranial direct current stimulation (tDCS) on binge eating disorder. [2022]

3. 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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Neuroimaging and neuromodulation approaches to study eating behavior and prevent and treat eating disorders and obesity. [2023]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Physical Therapy. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

8. United States 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. [2018]