RecruitingNot ApplicableNCT06273904

Modulating Escape Using Focused Ultrasound

Modulating Escape in the Anxiety Disorder Spectrum: Targeting the Direct Neural Mediator Using Transcranial Focused Ultrasound


Sponsor

Medical University of South Carolina

Enrollment

40 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a study to find out if a cutting-edge technology called transcranial focused ultrasound (tFUS) can be used to treat how people with anxiety or related concerns cope with emotional situations. tFUS is a brain stimulation technology that causes temporary changes in the activity of deep brain areas without a need for any surgery or other permanent or invasive procedures. This study is recruiting participants who recently started treatment for anxiety or a related concern to come in for 3 visits at the Medical University of South Carolina. At the first visit, participants will do interviews and surveys asking about anxiety and related concerns, and they do tasks where they respond to emotional pictures while brain activity is measured using magnetic resonance imaging (MRI). At the next two visits, participants again do a task where they see and react to emotional images, and this time the task is done once before and again once after receiving tFUS that either actively causes temporary changes (lasting for about an hour) in a targeted brain area or is not active (no changes elicited). At each tFUS visit, responses are measured with sensors worn on the hand, arms, face, and head (these visits do not involve MRI). Each visit in this study is expected to last between 2 - 3 hours. This study is not a treatment study, but it could help improve treatment in the future. Participants in this study are paid for their time.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether focused ultrasound — sound waves aimed at a specific brain region — can reduce anxiety-driven avoidance behaviors in people with anxiety disorders, PTSD, or OCD. The goal is to understand how this brain area influences the urge to escape or avoid feared situations. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with an anxiety disorder (generalized anxiety, panic disorder, social anxiety, or specific phobia), PTSD, OCD, or adjustment disorder with anxiety - You are currently seeking mental health treatment - English is your first or primary language **You may NOT be eligible if...** - You have a moderate or severe alcohol or substance use disorder - You have a lifetime diagnosis of a psychotic disorder or bipolar disorder - You have metal implants or other conditions that make ultrasound procedures unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive transcranial focused ultrasound (tFUS)

Active non-invasive low-intensity focused ultrasound will be delivered using a proprietary head-worn device and control software from Attune Neurosciences. On an active stimulation day, focused ultrasound will be delivered to the brain region of interest using parameters from published research that are demonstrated to safely cause temporary changes in the activity in that brain area.

DEVICESham transcranial focused ultrasound (tFUS)

Non-active low-intensity ultrasound will also be conducted using a proprietary head-worn device and control software from Attune Neurosciences. On the sham stimulation day, the device will be activated in a manner that produces similar sensory effects (i.e., low-volume beeping-type noise from the device) but also prevents delivery of a focused ultrasound beam to the brain area of interest or any other brain area.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06273904


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