What is the mechanism of action of this treatment?

Non-invasive brain stimulation techniques, such as Low Intensity Focused Ultrasound (LIFU), aim to target and modulate deep brain structures involved in depression, potentially altering neural activity and improving symptoms. This is significant for depression patients as it offers a non-pharmacologic option that can reach brain areas inaccessible by other methods. Other common treatments include antidepressant medications, which typically work by increasing levels of neurotransmitters like serotonin and norepinephrine, and psychotherapies like Cognitive Behavioral Therapy (CBT), which aim to change negative thought patterns. Understanding these mechanisms helps tailor treatments to individual needs, potentially improving outcomes and reducing side effects.

What side effects are associated with this type of intervention?

Common treatments for depression similar to Low Intensity Focused Ultrasound (LIFU) include Transcranial Magnetic Stimulation (TMS), Transcranial Direct Current Stimulation (tDCS), and Vagus Nerve Stimulation (VNS). TMS can cause side effects such as headaches, scalp discomfort, and, rarely, seizures. tDCS side effects are generally mild and include skin irritation at the electrode site and a tingling sensation. VNS may lead to voice changes, throat pain, and shortness of breath. These treatments are generally well-tolerated, but patients should discuss potential risks with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved several non-invasive brain stimulation treatments for depression. Transcranial Magnetic Stimulation (TMS) is one such treatment, approved for patients with major depressive disorder who have not responded to traditional antidepressant medications. TMS uses magnetic fields to stimulate nerve cells in the brain. Another FDA-approved treatment is Vagus Nerve Stimulation (VNS), which involves a device implanted under the skin that sends electrical impulses to the vagus nerve, influencing brain activity. These treatments are similar to Low Intensity Focused Ultrasound (LIFU) in that they aim to alter brain activity to alleviate symptoms of depression.

What other types of research exist?

Promising, novel alternatives to LIFU for treating depression include Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tDCS). TMS, particularly repetitive TMS (rTMS), has shown efficacy in reducing functional disability associated with depression. tDCS has also been studied for its potential to improve symptoms of depression by modulating brain activity through direct electrical stimulation.

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Non-invasive Brain Stimulation

Low Intensity Focused Ultrasound for Depression and Anxiety (LIFU Trial)

N/A

Recruiting

Led By Noah S Philip, MD

Research Sponsored by Ocean State Research Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy volunteers must have an absence of psychiatric disorders (>6 months; lifetime for major depression and PTSD) and absence of psychiatric medications or therapy for >6 months

Patients must meet DSM-5 criteria for major depressive disorder with and without anxiety symptoms

Must not have

History of seizure disorder or serious neurologic illness including dementia

History of brain surgery, pacemaker or implanted central nervous system device

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post lifu

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new brain stimulation method called low intensity focused ultrasound (LIFU) on veterans with depression and anxiety. LIFU uses sound waves to reach deep brain areas that current treatments can't. The study aims to see if LIFU is safe and effective in changing brain activity to help with these conditions.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the main focus is on safety and tolerability of LIFU for treating psychiatric conditions, potential side effects are not detailed but may include discomfort at stimulation site or temporary changes in mood or cognition due to brain activity alteration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had major depression, PTSD, or any psychiatric treatment for over 6 months.

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I have been diagnosed with major depression, with or without anxiety.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures or serious brain-related illnesses.

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I have had brain surgery or have a pacemaker/implanted CNS device.

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I have no significant abnormalities near the treatment area.

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My symptoms are not in the 'very severe' range.

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I do not have issues with my vision, hearing, or hand use that would affect medical assessments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post lifu

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post lifu

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post lifu for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BOLD fMRI Signal

Magnetic Resonance Imaging

Incidence of LIFU-related adverse events as assessed by neurological examinations

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Target Site Low Intensity Focused UltrasoundExperimental Treatment1 Intervention

Low Intensity focused ultrasound of the target region. These are at a fundamental frequency = 650kHz, PRF = 10Hz, pulse width = 5ms, duty cycle = 5%; ISPTA.3 of 720 mW/cm2. As in prior studies, each sonication includes 10 pulsations, each lasting 30s, followed by 30s pause intervals; two 10-minute administrations provided per LIFU session.

Group II: Control Site Low Intensity Focused UltrasoundActive Control1 Intervention

Low Intensity focused ultrasound of the control region. These are at a fundamental frequency = 650kHz, PRF = 10Hz, pulse width = 5ms, duty cycle = 5%; ISPTA.3 of 720 mW/cm2. As in prior studies, each sonication includes 10 pulsations, each lasting 30s, followed by 30s pause intervals; two 10-minute administrations provided per LIFU session.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Non-invasive brain stimulation techniques, such as Low Intensity Focused Ultrasound (LIFU), aim to target and modulate deep brain structures involved in depression, potentially altering neural activity and improving symptoms. This is significant for depression patients as it offers a non-pharmacologic option that can reach brain areas inaccessible by other methods. Other common treatments include antidepressant medications, which typically work by increasing levels of neurotransmitters like serotonin and norepinephrine, and psychotherapies like Cognitive Behavioral Therapy (CBT), which aim to change negative thought patterns. Understanding these mechanisms helps tailor treatments to individual needs, potentially improving outcomes and reducing side effects.

Changes in RNA expression levels during antidepressant treatment: a systematic review.Cingulum bundle white matter lesions influence antidepressant response in late-life depression: a pilot study.Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?