Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06273904

Modulating Escape Using Focused Ultrasound

Led by Medical University of South Carolina · Updated on 2025-10-14

40

Participants Needed

1

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Modulating Escape Using Focused Ultrasound

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Diagnosis of an anxiety disorder (Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Specific Phobia), posttraumatic stress disorder, obsessive-compulsive disorder, or current adjustment disorder with anxiety
  • Currently seeking mental health treatment
  • Able to read and provide informed consent
  • English is a first or primary fluent language
Not Eligible

You will not qualify if you...

  • Current alcohol or substance use disorder more than mild in severity
  • Lifetime diagnosis of psychotic disorder or bipolar mania
  • Neurological conditions contraindicating brain stimulation or neurophysiological recording, including seizure disorder
  • History of traumatic brain injury with loss of consciousness
  • Neurodegenerative disorders such as Alzheimer's, Parkinson's, or Frontotemporal Dementia
  • Medical conditions making it uncomfortable to sit or lie still for long periods
  • Standard contraindications for magnetic resonance imaging
  • Presence of metal in the body
  • Currently pregnant
  • Claustrophobia
  • Significant sensitivity to noise
  • Medical conditions or treatments that lower seizure threshold
  • History of severe brain injury
  • History of seizures or epilepsy
  • Taking anticholinergic, neuroleptic, or sedative/hypnotic medications
  • Taking chronic opiate medications or substances
  • Currently taking naltrexone
  • Note: Stable use of SSRIs, cholinesterase inhibitors, or NMDA receptor antagonists for at least four weeks prior to enrollment is allowed

AI-Screening

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Trial Site Locations

Total: 1 location

1

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

C

Christopher T Sege, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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