Ultrasonic Treatment of Food Addiction (USFADD)

Utah System of Higher Education (USHE)

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Overweight; Obesity

Treatments: Device: Sham stimulation with Diadem ultrasonic transducer array; Device: Active stimulation with Diadem ultrasonic transducer array

Study type: Interventional

Funder types: Other

Identifiers

NCT06249711

IRB_00175583

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Active stimulation

Active Comparator group

Description:

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

Treatment:

Device: Active stimulation with Diadem ultrasonic transducer array

Sham stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Sham stimulation with Diadem ultrasonic transducer array