OverweightPhase 1/2USFADDNCT06249711
Ultrasonic Treatment of Food Addiction
A Phase 1/2 study testing Active stimulation with Diadem ultrasonic transducer array in people with Overweight and Obesity, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Active stimulation with Diadem ultrasonic transducer array
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2024to 3 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Targeted Neuromodulation for Treatment of Food Addiction
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.
- Conditions
- Overweight, Obesity
- Being tested
- Active stimulation with Diadem ultrasonic transducer array, Sham stimulation with Diadem ultrasonic transducer array
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active stimulation with Diadem ultrasonic transducer arrayDevice
Diadem ultrasonic transducer array delivers focused low-intensity ultrasound stimulation
Sham stimulation with Diadem ultrasonic transducer arrayDevice
Diadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | Low-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction Receives: Device: Active stimulation with Diadem ultrasonic transducer array |
| Sham stimulation | Sham comparator | Zero-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction Receives: Device: Sham stimulation with Diadem ultrasonic transducer array |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The body weight will be taken prior to each intervention (once per week)
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.
Measured: Assessment at week 16
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.
Measured: During and immediately after each weekly intervention
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).
Measured: For up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start3 Mar 2024
- Primary completion3 Mar 2024
- Study completion3 Mar 2024
Why it stopped: Not activated at the site level
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Kubanek, University of Utah
- Investigators
- Jan Kubanek, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249711
- Sponsor's protocol ID
- IRB_00175583
- Acronym
- USFADD
- Status last verified
- Apr 2025
- First submitted
- 31 Jan 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Targeted Neuromodulation for Treatment of Food Addiction
- ClinicalTrials.gov ID
- NCT06249711
- Acronym / sponsor ID
- USFADD / IRB_00175583
- Conditions
- Overweight, Obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not activated at the site level
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 3 Mar 2024 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Device: Active stimulation with Diadem ultrasonic transducer arrayLow-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction |
| Sham stimulation | Sham comparator | Device: Sham stimulation with Diadem ultrasonic transducer arrayZero-intensity transcranial focused ultrasound stimulation of deep brain targets involved in food addiction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active stimulation with Diadem ultrasonic transducer arrayDiadem ultrasonic transducer array delivers focused low-intensity ultrasound stimulation | Device | Active stimulation |
| Sham stimulation with Diadem ultrasonic transducer arrayDiadem ultrasonic transducer array delivers focused zero-intensity ultrasound stimulation | Device | Sham stimulation |
Primary outcome
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Kubanek, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Active stimulation with Diadem ultrasonic transducer array in people with Overweight and Obesity, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.