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Procedure

Ultrasonic Treatment for Food Addiction (USFADD Trial)

Phase 1 & 2
Recruiting
Led By Jan Kubanek, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index more than or equal to 30 kg/m^2 or more than or equal to 25 kg/m^2 with the presence of at least one of the following weight-related comorbidities: hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease.
Be older than 18 years old
Must not have
Diabetic (HbA1c more than 48 mmol/mol or 6.5%)
A self-reported change in body weight more than 10 lbs within 60 days before screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for up to 16 weeks

Summary

This trial will test a new type of non-invasive therapy for food addiction using low-intensity ultrasound stimulation on the brain. The therapy will be tested on participants with monitoring to find the best stimulation settings

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include discomfort from wearing the transducer array or unknown reactions to ultrasound exposure as this is an investigational procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is 30 or higher, or it's 25 or higher with a condition like high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My HbA1c level is above 6.5%.
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I have lost or gained more than 10 lbs in the last 2 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessment at week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessment at week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in body weight (%) from baseline week 0 to week 16
Food Cravings Questionnaire-State
Hamilton Depression Rating Scale, 17 item
+1 more

Trial Design

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 Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,040 Total Patients Enrolled
16 Trials studying Obesity
2,634 Patients Enrolled for Obesity
Jan Kubanek, PhDPrincipal InvestigatorUniversity of Utah
2 Previous Clinical Trials
60 Total Patients Enrolled
~27 spots leftby Apr 2027
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