What side effects are associated with this type of intervention?

The most common treatments for Post-Traumatic Stress Disorder (PTSD) include pharmacologic therapies such as SSRIs (e.g., sertraline) and SNRIs (e.g., venlafaxine), and non-pharmacologic therapies like trauma-focused cognitive behavioral therapy (CBT). SSRIs and SNRIs can cause side effects such as nausea, insomnia, sexual dysfunction, and increased anxiety. Trauma-focused CBT is generally well-tolerated but may cause temporary increases in distress as patients confront traumatic memories. Neuromodulation treatments, like the one being studied with low-intensity focused ultrasound, are still experimental, and their side effects are not well-documented, but they may include headaches, dizziness, or discomfort at the stimulation site.

What prior FDA approvals exist?

The FDA has not approved any neuromodulation techniques, such as low-intensity focused ultrasound, specifically for the treatment of PTSD. However, pharmacologic treatments that have received FDA approval for PTSD include selective serotonin reuptake inhibitors (SSRIs) like sertraline and paroxetine. These medications work by modulating neurotransmitter levels in the brain, which can help alleviate PTSD symptoms. Other treatments, such as prazosin, have been used off-label to address specific symptoms like nightmares and sleep disturbances associated with PTSD.

What other types of research exist?

Promising novel alternatives to Low-Intensity Focused Ultrasound for treating PTSD include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown acceptability and potential benefits in military patients with stress-related symptoms, including PTSD. 2) Transcranial Magnetic Stimulation (TMS), which has been explored for its effects on brain function and has potential applications in PTSD treatment. 3) Neuromodulation devices, such as noninvasive median and radial nerve stimulation, which have shown efficacy in other neurological conditions and may be applicable to PTSD.

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Ultrasound Therapy

Focused Ultrasound Neuromodulation for Affective Disorders

Phase 2

Waitlist Available

Led By Gregory A Fonzo, Ph.D.

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

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

Must have

Willing and able to undergo the MRI and LIFUP procedures and repeated LIFUP for up to 15 sessions

Adults ages 18-65

Must not have

Contraindications to LIFUP or MRI including, but not limited to, history of stroke, brain tumors, brain hemorrhages, internal wires, electrodes, pacemakers, implants, irremovable ferromagnetic objects in head that are unsafe for MRI and/or cause large distortions in imaging data, history of seizures (except febrile seizures in childhood), brain surgery, moderate-to-severe head injury or any penetrating head injury, and uncontrolled thyroid disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, around 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment using sound waves to target a part of the brain in people with emotional disorders like depression and anxiety. The treatment aims to change how this part of the brain works to improve symptoms. It is non-invasive and uses MRI to monitor changes in the brain.

Who is the study for?

This trial is for adults aged 18-65 with a primary diagnosis of major depression, bipolar disorder, anxiety disorder, or PTSD. Participants must be proficient in English, able to undergo MRI and focused ultrasound treatments up to 15 times over 2-6 weeks, and have been on stable psychiatric medication for the past three months.

What is being tested?

The study tests low-intensity focused ultrasound (LIFUP) aimed at the left amygdala using MRI guidance. The goal is to see if this can improve symptoms of affective disorders. It's an open-label trial where participants receive daily LIFUP sessions five days a week for three weeks.

What are the potential side effects?

While ultrasound is generally safe when used diagnostically, potential side effects specific to this treatment are not detailed in the provided information but may include discomfort from repeated MRI scans and unknown risks from targeted brain modulation.

Eligibility Criteria

Inclusion Criteria

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

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I am willing and able to have up to 15 MRI and LIFUP sessions.

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I am between 18 and 65 years old.

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I have been diagnosed with a major mood or anxiety disorder.

Exclusion Criteria

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

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I do not have conditions like stroke, brain tumors, or metal implants that make MRI unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, around 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, around 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, around 6 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline fMRI activation to emotional stimuli at 6 weeks

Change from Baseline fMRI resting state connectivity at 6 weeks

Change from Baseline on the 30 item Mood and Anxiety Symptom Questionnaire General Distress Subscale score at 6 weeks

Secondary study objectives

Change from Baseline Alcohol Use Disorders Identification Test score at 6 weeks

Change from Baseline Anxiety Sensitivity Index 3 score at 6 weeks

Change from Baseline Beck Depression Inventory II score at 6 weeks.

+17 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open-label focused ultrasoundExperimental Treatment1 Intervention

Focused ultrasound at a 10 Hz pulse repetition frequency, 5% duty cycle, and 720 mw/cm squared de-rated spatial peak temporal average intensity, delivered over 10 min once a day, five days a week for 3 weeks.

0 / 4Eligibility 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

Common treatments for Post-Traumatic Stress Disorder (PTSD) include pharmacological options like selective serotonin reuptake inhibitors (SSRIs) and prazosin, as well as non-pharmacological therapies such as trauma-focused cognitive behavioral therapy (CBT) and exposure therapy. SSRIs work by increasing serotonin levels in the brain, which can help improve mood and reduce anxiety. Prazosin, an alpha-adrenergic receptor blocker, is often used to alleviate nightmares and improve sleep quality. Trauma-focused CBT and exposure therapy aim to help patients process traumatic memories and reduce PTSD symptoms through structured therapeutic techniques. These treatments are crucial for PTSD patients as they address both the psychological and physiological aspects of the disorder. The study of low-intensity focused ultrasound (LIFU) targeting the amygdala represents a novel approach, potentially modulating brain function to alleviate symptoms, which could offer new hope for patients who do not respond to traditional treatments.

Fully remote intensive trauma-focused treatment for PTSD and Complex PTSD.PTSD: from neurobiology to pharmacological treatments.Psychological therapies for post-traumatic stress disorder and comorbid substance use disorder.