Focused Ultrasound Neuromodulation for Affective Disorders

Overseen By Lauren Enten, B.S.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must be taking: Antidepressants, mood stabilizers

Must not be taking: Ketamine, esketamine

Disqualifiers: Stroke, brain tumors, cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for mood and anxiety disorders using focused ultrasound, a method often used for imaging. The goal is to determine if this treatment can improve symptoms by targeting the amygdala, a brain region involved in emotions. Participants will attend daily sessions for three weeks. This trial may suit individuals diagnosed with depression, bipolar disorder, anxiety disorders, or PTSD who maintain stable medication routines. As an unphased trial, it offers a unique opportunity to explore innovative treatments that could enhance emotional well-being.

Will I have to stop taking my current medications?

The trial requires that your psychiatric medications be on a stable dosage and regimen for the past 3 months, so you should not stop taking them if they meet this criterion.

What prior data suggests that this method is safe for modulating amygdala function?

Research has shown that focused ultrasound is generally safe for humans. Clinical trials suggest it could help treat mental health disorders that resist other treatments. Studies across various species, including humans, have demonstrated positive safety results, indicating the procedure did not cause serious side effects or harm. For instance, focused ultrasound has proven safe when used for brain conditions like epilepsy. As a non-invasive technique, it eliminates the need for surgery, reducing risk. Although more research is necessary to fully understand its safety in all situations, current findings are promising for its use in treating mood disorders. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Focused ultrasound is unique because it uses sound waves to non-invasively target brain areas associated with affective disorders, potentially offering a precise treatment without the need for surgery or medication. Unlike traditional methods such as antidepressants or psychotherapy, which can take weeks to show results, focused ultrasound aims to alter brain activity directly and rapidly. Researchers are excited about this innovative approach because it could provide quicker relief with fewer side effects, especially for patients who haven't responded well to existing treatments.

What evidence suggests that focused ultrasound is effective for affective disorders?

Research has shown that focused ultrasound, the treatment under study in this trial, might help improve symptoms in people with mood and anxiety disorders. One study found that patients with depression experienced noticeable emotional benefits after repeated treatments with low-intensity focused ultrasound. Another trial demonstrated that this method significantly reduced negative mood and anxiety symptoms. These findings suggest that focused ultrasound could be a promising treatment for mood disorders by targeting specific brain areas like the amygdala, which is involved in emotions. ^{1 3 6 7 8}

Who Is on the Research Team?

Gregory A Fonzo, Ph.D.

Principal Investigator

The University of Texas at Austin

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Score of 19 or greater on the general distress subscale of the 30-item Mood and Anxiety Symptom Questionnaire

English language proficiency sufficient to speak to investigators and understand investigator instruction

Exclusion Criteria

I am currently undergoing specific mental health treatments like CBT or TMS.

Current active suicidal/homicidal ideation (or suicide attempt in the past 3 months)

I do not have any serious illnesses like cancer, autism, or narcolepsy that could affect the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-intensity focused ultrasound targeting the left amygdala, once a day, 5 days a week, for 3 weeks

3 weeks

15 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Focused ultrasound

Trial Overview 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.

How Is the Trial Designed?

Group I: Open-label focused ultrasound Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12562471/

Using Low-Intensity Focused Ultrasound to Treat Depression ... This study demonstrated that patients with depressive symptoms might derive emotional benefits from repeated LIFU treatments. However, the ...

2. fusfoundation.org fusfoundation.org/posts/clinical-trial-results-focused-ultrasound-neuromodulation-improves-mood-anxiety-and-trauma-related-disorders/

Clinical Trial Results The primary outcome measures were rate of treatment completion and treatment response as measured by the Mood and Anxiety Symptom Questionnaire ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X25003055

A roadmap for focused ultrasound applications in psychiatry The two most studied and treated conditions in psychiatric neuromodulation are obsessive-compulsive disorder (OCD) and major depressive disorder (MDD). Both ...

4. nature.com nature.com/articles/s41380-025-03033-w

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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40275098/

a double-blind sham-controlled target engagement study and ... rtFUS was well-tolerated with no serious adverse events. There were significant reductions on the primary outcome (Mood and Anxiety Symptom ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278584624003129

Advances in transcranial focused ultrasound ... Clinical trials demonstrate tFUS safety and potential benefits in treatment-resistant mental disorders. •. Safety evaluations across species validate tFUS ...

7. biologicalpsychiatryjournal.com biologicalpsychiatryjournal.com/article/S0006-3223(25)00023-X/fulltext

Exploring a Novel Treatment for Severe Opioid Use Disorder NAc FUS neuromodulation is safe and a potential adjunctive treatment for reducing drug cravings and use in individuals with severe opioid and co-occurring ...

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01753-2

A panoramic review of transcranial focused ultrasound ... Safety of focused ultrasound neuromodulation in humans with Temporal lobe epilepsy. Brain Stimul. 2021;14(4):1022–31. Article PubMed Google ...