Recruiting

Focused Ultrasound

Sponsor:

Medical University of South Carolina

Code:

NCT06273904

Conditions

Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Active transcranial focused ultrasound (tFUS)

Sham transcranial focused ultrasound (tFUS)

Study Details

Brief 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.

Conditions

Anxiety Disorders

Study ID

NCT06273904

Start date

May 20, 2024

Status verified date

Oct, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18-65 y.o.
  • Meets criteria for 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
  • Is currently seeking mental health treatment
  • Is able to read consent document and provide informed consent.
  • English is a first or primary fluent language.

Exclusion Criteria:

  • Current alcohol or substance use disorder of more than mild severity (as defined by the Diagnostic and Statistical Manual (DSM)-5 and determined using standardized self-report instruments)
  • Lifetime diagnosis of psychotic disorder or bipolar mania
  • Presence of neurological disorder that contraindicates brain stimulation or neurophysiological recording: Seizure disorder
  • Lifetime history of traumatic brain injury with loss of consciousness
  • Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)
  • Presence of other medical disorder that would make it too uncomfortable to sit or lie still for long recording periods
  • Presence of standard contraindications for magnetic resonance imaging
  • 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/ epilepsy
  • Currently taking anticholinergic mediation, neuroleptic medication, or sedative/ hypnotic medication

Note: selective serotonin re-uptake inhibitors (SSRIs), cholinesterase inhibitors or N-methyl-D-aspartate (NMDA) receptor antagonists are allowed if patient has been on a stable regimen of four weeks prior to enrollment

  • Currently taking chronic opiate medications or substances
  • Currently taking naltrexone

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Group Receiving Active Stimulation and Sham Stimulation on Separate Days (All Participants)

All participants will receive active stimulation and non-active (sham) stimulation on different days. Before the stimulation sessions, all participants will complete experimental tasks during functional magnetic resonance imaging. On the next two study days, all participants will complete tasks before and after receiving active transcranial focused ultrasound (tFUS) on one day and sham (non-active) tFUS on another day. Stimulation (active or sham) is conducted briefly (< 10 minutes) in between tasks, not during tasks.

Interventions

Active 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.

Sham 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.

Primary outcome measure

  • Change in Fear-Potentiated Startle Reflex [ Time Frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments) ]

Central Contacts and Locations

Central contacts

Christopher T Sege, PhD

(843) 501-1718sege@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Christopher T Sege

9787641480sege@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-10-14.