Low-Intensity Focused Ultrasound for Gambling Addiction
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn whether low-intensity focused ultrasound (LIFU) is safe and may help reduce gambling-related symptoms in adults seeking treatment for gambling disorder.
The main questions it aims to answer are:
* Is LIFU safe and well tolerated in adults with gambling disorder?
* Does LIFU reduce gambling behavior compared with a sham (inactive) procedure?
Researchers will compare participants who receive active LIFU with participants who receive sham LIFU to see whether active treatment leads to greater reductions in gambling behavior.
Participants will:
* Be randomly assigned to receive either active LIFU or sham LIFU.
* Receive nine treatment sessions delivered over three treatment days within a five-day period.
* Participate in weekly telehealth cognitive behavioral therapy (CBT).
* Complete assessments of gambling behavior, gambling urges, mood, and quality of life.
* Attend follow-up visits for up to 90 days after active LIFU treatment.
Low-intensity focused ultrasound is a noninvasive technique that uses focused sound waves to influence brain activity. Researchers believe this approach may affect brain circuits involved in reward, cravings, and decision-making that contribute to gambling disorder.
Are You a Good Fit for This Trial?
This trial is for adults seeking treatment for gambling disorder. Participants must be willing to attend multiple sessions and follow-up visits. People with certain medical or psychiatric conditions may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Low-Intensity Focused Ultrasound (LIFU)
Trial Overview
The study tests whether low-intensity focused ultrasound (LIFU), a noninvasive brain stimulation technique, can safely reduce gambling behaviors compared to a sham (inactive) procedure. All participants also receive weekly telehealth therapy.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Device: Low Intensity Focused Ultrasound * Each course comprises of three 10-minute sessions of Active LIFU per day (5 minutes to the left NAc, then 5 minutes to the right) on three treatment days scheduled within a 5-day window (i.e., nine sessions per course). * During the randomized phase (through post-LIFU Day 30), the trial operates as a parallel-group comparison of active LIFU versus sham, with both arms receiving standard-of-care, once-weekly telehealth CBT.
Device: Low Intensity Focused Ultrasound * Each course comprises of three 10-minute sessions of Sham LIFU per day (5 minutes to the left NAc, then 5 minutes to the right) on three treatment days scheduled within a 5-day window (i.e., nine sessions per course). * Sham session is procedurally identical to Active LIFU session with the exception that no energy is delivered during the procedures. * During the randomized phase (through post-LIFU Day 30), the trial operates as a parallel-group comparison of active LIFU versus sham, with both arms receiving standard-of-care once-weekly telehealth CBT. * After the Day 30 primary endpoint and unblinding, the sham arm crosses over to open-label active LIFU and repeats the identical treatment and assessment sequence, so every participant ultimately receives active treatment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Virginia
Lead Sponsor
NaviFUS Corporation
Industry Sponsor
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