Modulating Escape Using Focused Ultrasound

NCT06273904 | Recruiting FDA Device

• 1 other identifier: Pro00132631
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Fear-Potentiated Startle Reflex

  Fear-potentiated startle is measured during an experimental task in which participants prepare to avoid, escape, or simply be exposed to aversive pictures. Fear-potentiated startle measures motivational activation during the preparation period.

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)

Secondary Outcomes (8)

• Change in speed to initiate avoidance behavior

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)

• Change in Electroencephalography (EEG)-Assessed Contingent Negative Variation During Escape/ Avoidance Preparation

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)

• Change in Electroencephalography (EEG)-Assessed N200 During Implicit Approach/ Avoid Bias Assessment

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)

• Change in Electroencephalography (EEG)-Assessed Theta-Band Power During Behavioral Tasks

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)

• Change in High-Frequency Heart Rate Variability/ Respiratory Sinus Arrhythmia

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)

Other Outcomes (1)

• Task-Related Regional Brain Activation

  During Session (Approx. 45 minutes)

Study Arms (1)

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

EXPERIMENTAL

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.

Device: Active transcranial focused ultrasound (tFUS); Device: Sham transcranial focused ultrasound (tFUS)

Interventions

Active transcranial focused ultrasound (tFUS) DEVICE

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.

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

Sham transcranial focused ultrasound (tFUS) DEVICE

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Christopher Sege, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher T Sege, PhD

CONTACT

(843) 501-1718; sege@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor-Faculty

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 23, 2024
• Study Start: May 20, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)