20 Participants Needed

Focused Ultrasound Neuromodulation for Affective Disorders

LE
Overseen ByLauren Enten, B.S.A.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas at Austin
Must be taking: Antidepressants, mood stabilizers
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

GA

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
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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.
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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?
1Treatment groups
Experimental Treatment
Group I: Open-label focused ultrasoundExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

Citations

Transcranial Focused Ultrasound to the Right Prefrontal Cortex Improves Mood and Alters Functional Connectivity in Humans. [2020]
Neuromodulation with transcranial focused ultrasound. [2020]
Transcranial Focused Ultrasound (tFUS) and Transcranial Unfocused Ultrasound (tUS) Neuromodulation: From Theoretical Principles to Stimulation Practices. [2020]
Transcranial Focused Ultrasound Neuromodulation: A Review of the Excitatory and Inhibitory Effects on Brain Activity in Human and Animals. [2023]
Transcranial focused ultrasound: a new tool for non-invasive neuromodulation. [2022]
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