Ultrasonic Treatment of Food Addiction

Obesity Clinical Trial

— USFADD  

Official title:

Noninvasive Targeted Neuromodulation for Treatment of Food Addiction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249711
• Other study ID #: IRB_00175583
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 8, 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
• 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

Related Conditions & MeSH terms

• Food Addiction
• Obesity
• Overweight

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