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Ultrasonic Treatment of Food Addiction

NCT06249711 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-05-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Jan Kubanek, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-03
Primary Completion
2024-03-03
Completion
2024-03-03

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249711 on ClinicalTrials.gov