Ultrasonic Treatment of Food Addiction

NCT ID: NCT06249711

Last Updated: 2025-05-22

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-03

Study Completion Date

2024-03-03

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active stimulation

Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction

Group Type ACTIVE_COMPARATOR

Active stimulation with Diadem ultrasonic transducer array

Intervention Type DEVICE

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

Group Type SHAM_COMPARATOR

Sham stimulation with Diadem ultrasonic transducer array

Intervention Type DEVICE

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

Intervention Type DEVICE

Sham stimulation with Diadem ultrasonic transducer array

Diadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Jan Kubanek

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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IRB_00175583

Identifier Type: -

Identifier Source: org_study_id

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