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)

Trial Summary

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 data supports the effectiveness of the treatment Low Intensity Focused Ultrasound for Depression and Anxiety?

Research suggests that Low Intensity Focused Ultrasound (LIFU) can safely and precisely modulate brain activity, offering a non-invasive way to potentially improve outcomes in psychiatric conditions like depression. It has shown promise in modulating brain regions involved in psychiatric illnesses, and studies in animals have indicated it may reduce depression-like behaviors.12345

How is Low Intensity Focused Ultrasound (LIFU) different from other treatments for depression and anxiety?

Low Intensity Focused Ultrasound (LIFU) is unique because it is a non-invasive brain stimulation technique that uses sound waves to target specific brain areas, unlike traditional treatments like medication or talk therapy. This method is similar to Low-Field Magnetic Stimulation (LFMS), which also offers rapid mood-enhancing effects, but LIFU uses ultrasound instead of magnetic fields.678910

What is the purpose of this trial?

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.

Research Team

NS

Noah S Philip, MD

Principal Investigator

VA Providence Healthcare System

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ocean State Research Institute, Inc.

Lead Sponsor

Trials
3
Recruited
280+

Findings from Research

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]
Low-intensity focused ultrasound (LIFU) is a promising noninvasive technique for neuromodulation that could improve treatment outcomes for patients with Major Depressive Disorder (MDD) and Obsessive-Compulsive Disorder (OCD) who do not respond to traditional therapies.
Current psychosurgical techniques, such as deep-brain stimulation, have variable success rates, with only about half of patients showing adequate response, highlighting the need for innovative approaches like LIFU to enhance personalized treatment strategies.
Personalized Definition of Surgical Targets in Major Depression and Obsessive-Compulsive Disorder: A Potential Role for Low-Intensity Focused Ultrasound?Guinjoan, SM.[2023]
Low intensity focused ultrasound (LIFU) is a promising non-invasive technology that can precisely modulate brain activity, offering a new approach to studying and potentially treating psychiatric illnesses.
LIFU has been shown to safely affect both cortical and subcortical brain regions, distinguishing it from other neuromodulatory techniques due to its spatial precision and reversible effects.
Low Intensity Focused Ultrasound for Non-invasive and Reversible Deep Brain Neuromodulation-A Paradigm Shift in Psychiatric Research.Arulpragasam, AR., van 't Wout-Frank, M., Barredo, J., et al.[2022]

References

Transcranial focused ultrasound stimulation with high spatial resolution. [2021]
Personalized Definition of Surgical Targets in Major Depression and Obsessive-Compulsive Disorder: A Potential Role for Low-Intensity Focused Ultrasound? [2023]
Low Intensity Focused Ultrasound for Non-invasive and Reversible Deep Brain Neuromodulation-A Paradigm Shift in Psychiatric Research. [2022]
Low-intensity pulsed ultrasound ameliorates depression-like behaviors in a rat model of chronic unpredictable stress. [2021]
Evaluation of a Novel Acoustic Coupling Medium for Human Low-Intensity Focused Ultrasound Neuromodulation Applications. [2023]
A double-blind pilot dosing study of low field magnetic stimulation (LFMS) for treatment-resistant depression (TRD). [2023]
Double-blind, proof-of-concept (POC) trial of Low-Field Magnetic Stimulation (LFMS) augmentation of antidepressant therapy in treatment-resistant depression (TRD). [2022]
Alteration of cortico-limbic-striatal neural system in major depressive disorder and bipolar disorder. [2018]
[Research on amplitude of low-frequency fluctuation in patients with major depression based on resting-state functional magnetic resonance imaging]. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Amplitude of low-frequency oscillations in first-episode, treatment-naive patients with major depressive disorder: a resting-state functional MRI study. [2022]
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