25 Participants Needed

Low Intensity Focused Ultrasound for Depression and Anxiety

(LIFU Trial)

NS
EA
Overseen ByEmily Aiken, MA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ocean State Research Institute, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

NS

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

I haven't had major depression, PTSD, or any psychiatric treatment for over 6 months.
I have been diagnosed with major depression, with or without anxiety.
I have noticeable symptoms and have been on stable treatment for over 6 weeks.

Exclusion Criteria

I have a history of seizures or serious brain-related illnesses.
Greater than moderate alcohol or substance use disorders (last six months; excluding nicotine/caffeine)
I have had brain surgery or have a pacemaker/implanted CNS device.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive LIFU application during two visits, with neuroimaging and neuropsychological testing

6 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including safety assessments and neurological exams

6 months
Up to 6 visits (in-person)

Extension

Optional extended follow-up for additional safety monitoring and assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Low Intensity Focused Ultrasound
Trial Overview The study tests Low Intensity Focused Ultrasound (LIFU) as a non-invasive way to target deep brain structures linked to depression and anxiety. It will assess safety and ability of LIFU to alter brain activity during tasks. Participants undergo up to 14 visits including neuroimaging and neuropsychological testing; some receive LIFU while performing tasks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Target Site Low Intensity Focused UltrasoundExperimental Treatment1 Intervention
Group II: Control Site Low Intensity Focused UltrasoundActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ocean State Research Institute, Inc.

Lead Sponsor

Trials
3
Recruited
280+

Published Research Related to This Trial

In a study involving 36 participants (18 with major depressive disorder and 18 healthy controls), patients with MDD exhibited increased amplitude of low-frequency oscillations (ALFF) in specific brain regions like the right fusiform gyrus and cerebellum, indicating altered brain activity associated with depression.
The findings suggest that these changes in LFO amplitude across various brain regions may be linked to emotional and cognitive disturbances in MDD, providing insights into the underlying network imbalances related to the disorder.
Amplitude of low-frequency oscillations in first-episode, treatment-naive patients with major depressive disorder: a resting-state functional MRI study.Wang, L., Dai, W., Su, Y., et al.[2022]
In a study involving 13 patients with major depressive disorder (MDD) and 14 healthy controls, resting-state fMRI revealed that MDD patients had significantly higher brain activity in the right medial prefrontal area compared to controls.
Conversely, MDD patients showed significantly lower brain activity in the left parietal region, suggesting that these alterations in brain activity may help explain the underlying mechanisms of depression.
[Research on amplitude of low-frequency fluctuation in patients with major depression based on resting-state functional magnetic resonance imaging].Qiu, H., Liu, H., He, Q., et al.[2018]
The dual-crossed transducer system achieved high spatial resolution in targeting small brain regions in mice, with a focal volume of under 0.52 μm³ and a focal diameter of 1 mm, making it effective for precise neuromodulation.
In vivo experiments demonstrated successful brain stimulation in wild-type mice, evidenced by observable movements, confirming the system's capability for noninvasive and specific targeting of brain circuits.
Transcranial focused ultrasound stimulation with high spatial resolution.Kim, S., Jo, Y., Kook, G., et al.[2021]

Citations

Low intensity focused ultrasound - NIH RePORTERPROJECT SUMMARY/ABSTRACT Current treatments for depression and anxiety are often limited by partial efficacy and significant side effects.
A Comprehensive Review of Low-Intensity Focused ...Low-intensity focused ultrasound (LIFU) is gaining increased interest as a potential therapeutic modality for a range of neuropsychiatric diseases.
NCT05147142 | Low Intensity Focused Ultrasound: a New ...In this study, the investigators will test if this technique can be used to change brain activity in areas that are connected to depression and anxiety symptoms ...
Effect of Low-Intensity Transcranial Focused Ultrasound ...For example, significant improvements in emotional symptoms, including depression, anxiety, and other aspects of mood state (evaluated through ...
Low-intensity transcranial focused ultrasound amygdala ...We observed a significant reduction on our primary outcome, a general measure of negative affect symptoms in MATRDs. The effect was ...
NCT05147142 | Low Intensity Focused Ultrasound: a New ...In this study, the investigators will test if this technique can be used to change brain activity in areas that are connected to depression and anxiety symptoms ...
Clinical Trial Investigates Low-Intensity ...Preliminary data show that LIFU may be able to reach deep structures of the brain involved with depression and anxiety that traditional ...
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