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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is focused ultrasound treatment different from other treatments for affective disorders?

Focused ultrasound treatment is unique because it is non-invasive and can precisely target deep brain areas involved in mood regulation, unlike other methods like transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS). This allows for high spatial resolution and the ability to modulate specific brain circuits without surgery. ^{1 2 3 4 5}

Research Team

Gregory A Fonzo, Ph.D.

Principal Investigator

The University of Texas at Austin

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Focused Ultrasound to the Right Prefrontal Cortex Improves Mood and Alters Functional Connectivity in Humans. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation with transcranial focused ultrasound. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Focused Ultrasound (tFUS) and Transcranial Unfocused Ultrasound (tUS) Neuromodulation: From Theoretical Principles to Stimulation Practices. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Focused Ultrasound Neuromodulation: A Review of the Excitatory and Inhibitory Effects on Brain Activity in Human and Animals. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Transcranial focused ultrasound: a new tool for non-invasive neuromodulation. [2022]