Obesity, Overweight
Conditions
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.
Interventions
DEVICEActive stimulation with Diadem ultrasonic transducer array
Diadem ultrasonic transducer array delivers focused low-intensity ultrasound stimulation
DEVICESham stimulation with Diadem ultrasonic transducer array
Diadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight (%) from baseline week 0 to week 16 | The body weight will be taken prior to each intervention (once per week) | The body weight will be quantified with respect to baseline (100%), taken prior to the first intervention. |
| Number of participants who achieved body weight reduction >= 5% | Assessment at week 16 | Proportion of subjects who have lost at least 5% of their weight at week 16 relative to the baseline week 0. |
| Food Cravings Questionnaire-State | During and immediately after each weekly intervention | 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. |
| Hamilton Depression Rating Scale, 17 item | For up to 16 weeks | This 17-item questionnaire measures the severity of depression. Scores range between 0 (least severe) to 52 (most severe). |
Countries
United States
Outcome results
None listed