Ultrasonic Treatment of Food Addiction

Phase 1

Withdrawn

• Conditions: Obesity; Overweight
• Interventions: Device: Sham stimulation with Diadem ultrasonic transducer array; Device: Active stimulation with Diadem ultrasonic transducer array

• Registration Number: NCT06249711
• Lead Sponsor: University of Utah

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Study First Posted: 2024-02-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30
• Study Start: 2025-09-01
• Primary Completion: 2027-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Sham stimulation with Diadem ultrasonic transducer array	Zero-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction
Active stimulation	Active stimulation with Diadem ultrasonic transducer array	Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction

Primary Outcome Measures

Name	Time	Method
Change in body weight (%) from baseline week 0 to week 16	The body weight will be taken prior to each intervention (once per week)	The body weight will be quantified with respect to baseline (100%), taken prior to the first intervention.
Number of participants who achieved body weight reduction >= 5%	Assessment at week 16	Proportion of subjects who have lost at least 5% of their weight at week 16 relative to the baseline week 0.
Food Cravings Questionnaire-State	During and immediately after each weekly intervention	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.
Hamilton Depression Rating Scale, 17 item	For up to 16 weeks	This 17-item questionnaire measures the severity of depression. Scores range between 0 (least severe) to 52 (most severe).

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States