NCT06249711

Ultrasonic Treatment of Food Addiction

Noninvasive Targeted Neuromodulation for Treatment of Food Addiction

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DEVICE	Active stimulation with Diadem ultrasonic transducer array	Diadem ultrasonic transducer array delivers focused low-intensity ultrasound stimulation
DEVICE	Sham stimulation with Diadem ultrasonic transducer array	Diadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation

Timeline

• Start date: 2024-03-03
• Primary completion: 2024-03-03
• Completion: 2024-03-03
• First posted: 2024-02-08
• Last updated: 2025-05-22

Locations

1 site across 1 country: United States