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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, around 6 weeks
Awards & highlights

Study Summary

This trial will use ultrasound to target the amygdala, the part of the brain associated with emotion, in order to improve symptoms of an affective disorder.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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.

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
81,224 Total Patients Enrolled
Gregory A Fonzo, Ph.D.Principal InvestigatorThe University of Texas at Austin
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Focused ultrasound (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05228964 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Open-label focused ultrasound
Post-Traumatic Stress Disorder Clinical Trial 2023: Focused ultrasound Highlights & Side Effects. Trial Name: NCT05228964 — Phase 2
Focused ultrasound (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05228964 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05228964 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elucidate the potential hazards of Focused ultrasound?

"Due to the absence of clinical data supporting its efficacy, Focused ultrasound received a safety rating of 2. Nevertheless, some evidence exists demonstrating it is not entirely unsafe."

Answered by AI

What criteria need to be fulfilled in order for someone to qualify as a participant of this investigation?

"To be considered for this medical experiment, applicants must have an anxiety disorder and meet the age prerequisite of 18-65 years old. Ultimately, 20 participants will be chosen to take part in the study."

Answered by AI

Is this research project currently in search of participants?

"Per the information listed on clinicaltrials.gov, this trial is actively searching for study participants. It was first posted on January 13th 2022 and received its most recent update a fortnight later, on January 26th of that same year."

Answered by AI

What aim is this research attempting to achieve?

"The primary aim of this clinical trial, which is to be monitored over a 6-week period, will ascertain the difference in fMRI activation when exposed to emotional stimuli. Secondary objectives include evaluating changes from baseline on the Conor Davidson Resiliency Scale (scores range 0 - 40; higher indicating greater resiliency), Spielberger State-Trait Anxiety Inventory (0 - 60 for each sub scale with lower scores signifying less anxiety) and Beck Depression Inventory II (0 - 63 with lower scores representing fewer depression symptoms)."

Answered by AI

Are applicants below the age of 30 considered for inclusion in this research project?

"This medical research is accepting applicants who are between 18 and 65 years of age."

Answered by AI

How many participants are accepted into this research endeavor?

"Affirmative. The information published on clinicaltrials.gov demonstrates that this trial is actively recruiting volunteers, with the first posting having been made on January 13th 2022 and last modified one fortnight later. This study requires 20 participants from a single location to be recruited in order to progress further."

Answered by AI

Who else is applying?

What state do they live in?
Utah
Texas
Oklahoma
How old are they?
18 - 65
What site did they apply to?
Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I have tried everything I am stuck. Id really like to feel better, I feel very alone.
PatientReceived 2+ prior treatments
I have tried many antidepressants. Most of the time they have been effective for years. When it no longer works I’m prescribed a new drug.
PatientReceived 1 prior treatment
I've tried many different modalities. Medication, trauma therapy, rTMS, Neurofeedback, Ketamine, acupuncture, working out, and eating very healthy aka mostly high quality animal protein and fresh fruits and vegetables. All these modalities have helped me to some degree however none of them even combined have got me to a fully steady balanced place mentally and emotionally. I'd love to try low intensity focused ultrasound and be a small part of something that potentially helps so many other people who are struggling. Thank you for considering me.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Do we have to pay for our own travel expenses?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Focused Ultrasound Amygdala Neuromodulation
Greg Fonzo 2022. "Focused Ultrasound Amygdala Neuromodulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05228964.
All > Ptsd Austin > Focused Ultrasound
~2 spots leftby Oct 2024
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