Ultrasonic Treatment of Food Addiction

Phase

1/2

Condition

Addictions

Bulimia

Obesity

Treatment

Sham stimulation with Diadem ultrasonic transducer array

Active stimulation with Diadem ultrasonic transducer array

Clinical Study ID

NCT06249711

IRB_00175583

Ages 18-75
All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

History of at least one self-reported unsuccessful dietary effort to lose bodyweight
Body mass index more than or equal to 30 kg/m^2 or more than or equal to 25 kg/m^2with the presence of at least one of the following weight-related comorbidities:hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease.

Exclusion

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 beforescreening
Clinically inappropriate for participation in the study as determined by the studyteam

Study Design