Low Intensity Focused Ultrasound for Depression and Anxiety
(LIFU Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method called low intensity focused ultrasound (LIFU) to determine if it can safely and effectively alter brain activity related to depression and anxiety. The goal is to reach deeper brain areas that current treatments cannot target well. Participants will receive LIFU either before or during a task to help researchers understand its impact. Veterans diagnosed with major depressive disorder, with or without anxiety symptoms, who have been stable on treatments for more than six weeks, might be suitable for this trial. As an unphased trial, this study offers the opportunity to contribute to groundbreaking research that could lead to new treatment options.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients should be on stable treatments for more than 6 weeks, which suggests you may continue your current medications if they are stable.
What prior data suggests that this technique is safe for treating depression and anxiety?
Research has shown that low intensity focused ultrasound (LIFU) is generally well-tolerated by patients. Studies have found that LIFU can safely reach deep brain areas associated with depression and anxiety without causing major side effects. A review of both human and animal studies found that LIFU has a good safety record with few reported negative effects. In earlier studies, patients who underwent LIFU experienced minimal discomfort, with most side effects being mild and temporary, such as slight scalp tingling or a brief headache. These findings suggest that LIFU is a safe option for exploring new treatments for mental health conditions.12345
Why are researchers excited about this trial?
Researchers are excited about Low Intensity Focused Ultrasound (LIFU) for depression and anxiety because it offers a non-invasive alternative to traditional treatments like medication and psychotherapy. Unlike medications, which can take weeks to show effectiveness and might have side effects, LIFU uses sound waves to target specific brain regions, potentially offering quicker results with fewer side effects. This innovative approach could provide a new way to manage symptoms by directly modulating brain activity without the need for surgery or drugs.
What evidence suggests that Low Intensity Focused Ultrasound is effective for depression and anxiety?
Research has shown that low intensity focused ultrasound (LIFU) could help treat depression and anxiety. In some studies, patients experienced noticeable improvements in their emotional symptoms. This trial will compare two different applications of LIFU: one targeting a specific brain region and another targeting a control region. LIFU reaches parts of the brain that are difficult to target with other treatments. These brain areas often connect to feelings of depression and anxiety. Early findings suggest that LIFU can alter brain activity in a way that might relieve symptoms.13467
Who Is on the Research Team?
Noah S Philip, MD
Principal Investigator
VA Providence Healthcare System
Are You a Good Fit for This Trial?
This trial is for veterans with depression and/or anxiety who have been stable on treatments for over 6 weeks. Healthy volunteers without psychiatric disorders or medications in the past 6 months can also join. Exclusions include those with brain surgery, severe head injuries, substance abuse issues, pacemakers, metal in the head, severe vision/hearing/hand impairments, pregnancy, inability to follow protocols or very severe symptoms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive LIFU application during two visits, with neuroimaging and neuropsychological testing
Follow-up
Participants are monitored for safety and effectiveness after treatment, including safety assessments and neurological exams
Extension
Optional extended follow-up for additional safety monitoring and assessments
What Are the Treatments Tested in This Trial?
Interventions
- Low Intensity Focused Ultrasound
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ocean State Research Institute, Inc.
Lead Sponsor