Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2024-03-03
2024-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active stimulation
Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction
Active stimulation with Diadem ultrasonic transducer array
Diadem ultrasonic transducer array delivers focused low-intensity ultrasound stimulation
Sham stimulation
Zero-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction
Sham stimulation with Diadem ultrasonic transducer array
Diadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Jan Kubanek
Assistant Professor
Principal Investigators
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Jan Kubanek, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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IRB_00175583
Identifier Type: -
Identifier Source: org_study_id
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