Ultrasonic Treatment of Food Addiction (NCT06249711) | Clinical Trial Compass
WithdrawnPhase 1/2
Ultrasonic Treatment of Food Addiction
Stopped: Not activated at the site level
United States0Started 2024-03-03
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in body weight (%) from baseline week 0 to week 16
Timeframe: The body weight will be taken prior to each intervention (once per week)
2
Number of participants who achieved body weight reduction >= 5%
Timeframe: Assessment at week 16
3
Food Cravings Questionnaire-State
Timeframe: During and immediately after each weekly intervention