Ultrasonic Treatment of Food Addiction

NCT06249711 | Withdrawn Phase 1

• 1 other identifier: IRB_00175583
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (4)

• 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)

• 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

• 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

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction

Device: Active stimulation with Diadem ultrasonic transducer array

Sham stimulation

SHAM COMPARATOR

Zero-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction

Device: Sham stimulation with Diadem ultrasonic transducer array

Interventions

Active stimulation with Diadem ultrasonic transducer array DEVICE

Diadem ultrasonic transducer array delivers focused low-intensity ultrasound stimulation

Active stimulation

Sham stimulation with Diadem ultrasonic transducer array DEVICE

Diadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84103, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Kubanek, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: March 3, 2024
• Primary Completion: March 3, 2024
• Study Completion: March 3, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)