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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Active Comparator | Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction |
|
| Sham stimulation | Sham Comparator | Zero-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active stimulation with Diadem ultrasonic transducer array | Device | Diadem ultrasonic transducer array delivers focused low-intensity ultrasound stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Kubanek, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84103 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Sham stimulation with Diadem ultrasonic transducer array | Device | Diadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |