Ultrasonic Treatment of Food Addiction

University of Utah

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Overweight Obesity

Interventions

Active stimulation with Diadem ultrasonic transducer arrayDEVICE

Diadem ultrasonic transducer array delivers focused low-intensity ultrasound stimulation

Sham stimulation with Diadem ultrasonic transducer arrayDEVICE

Diadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: For up to 16 weeks

Data from ClinicalTrials.gov

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