Noninvasive Targeted Neuromodulation for Treatment of Food Addiction
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- University of Utah
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in body weight (%) from baseline week 0 to week 16
- Status
- Withdrawn
- Last Updated
- 11 months ago
Overview
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.
Investigators
Jan Kubanek
Assistant Professor
University of Utah
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in body weight (%) from baseline week 0 to week 16
Time Frame: 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%
Time Frame: 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
Time Frame: 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
Time Frame: For up to 16 weeks
This 17-item questionnaire measures the severity of depression. Scores range between 0 (least severe) to 52 (most severe).