Ultrasonic Treatment of Food Addiction (USFADD)

Noninvasive Targeted Neuromodulation for Treatment of Food Addiction

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Overweight
• Intervention / Treatment: Device: Active stimulation with Diadem ultrasonic transducer array; Device: Sham stimulation with Diadem ultrasonic transducer array

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Lifetime history of a serious suicide attempt
• MRI intolerance or contraindication
• Pregnant or breast feeding
• 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
• Clinically inappropriate for participation in the study as determined by the study team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active stimulation; Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction	Device: Active stimulation with Diadem ultrasonic transducer array; Diadem ultrasonic transducer array delivers focused low-intensity ultrasound stimulation
Sham Comparator: Sham stimulation; Zero-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction	Device: Sham stimulation with Diadem ultrasonic transducer array; Diadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who achieved body weight reduction >= 5%	Proportion of subjects who have lost at least 5% of their weight at week 16 relative to the baseline week 0.	Assessment at week 16
Food Cravings Questionnaire-State	This 15-item questionnaire measures immediate level of food craving, each item ranging from 1 (strongly disagree) to 5 (strongly agree). Higher total scores indicate stronger desire to eat.	During and immediately after each weekly intervention
Change in body weight (%) from baseline week 0 to week 16	The body weight will be quantified with respect to baseline (100%), taken prior to the first intervention.	The body weight will be taken prior to each intervention (once per week)
Hamilton Depression Rating Scale, 17 item	This 17-item questionnaire measures the severity of depression. Scores range between 0 (least severe) to 52 (most severe).	For up to 16 weeks

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Jan Kubanek, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2024
• Primary Completion (Actual): March 3, 2024
• Study Completion (Actual): March 3, 2024

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Feeding and Eating Disorders; Food Addiction; Overweight
• Other Study ID Numbers: IRB_00175583

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No