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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06249711
Other study ID # IRB_00175583
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 22, 2024
Est. completion date April 1, 2027

Study information

Verified date May 2024
Source University of Utah
Contact Jan Kubane, PhD
Phone 801-213-1418
Email jan.kubanek@utah.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 1, 2027
Est. primary completion date April 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Active stimulation with Diadem ultrasonic transducer array
Diadem ultrasonic transducer array delivers focused low-intensity ultrasound stimulation
Sham stimulation with Diadem ultrasonic transducer array
Diadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation

Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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
Primary 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
Primary 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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