Anxiety DisordersNCT06273904
Modulating Escape Using Focused Ultrasound
A study testing Active transcranial focused ultrasound (tFUS) in people with Anxiety Disorders, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Active transcranial focused ultrasound (tFUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Christopher T Sege, 9787641480, sege@musc.edu
About this study
Official title: Modulating Escape in the Anxiety Disorder Spectrum: Targeting the Direct Neural Mediator Using Transcranial Focused Ultrasound
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.
Read the detailed description
Escape and avoidance are core targets of anxiety and related disorder treatment, but such behaviors also often persist even after reduction of reported symptoms or they keep an individual from engaging in treatment at all. Novel methods to directly target motive drivers of escape/ avoidance coping early in treatment are needed to improve retention and outcome especially for the 20% of individuals who do not benefit from and 40% who do not complete treatment. Basic science identifies multiple neural mediators of real-world escape and avoidance, and it suggests these mediators may not be directly or adequately targeted by current treatment techniques. Moreover, the direct neural mediators may be primarily subcortical and thus not be accessible to therapeutic technologies like transcranial magnetic stimulation that can only stimulate cortical areas. A novel technology called transcranial focused ultrasound (tFUS), meanwhile, has demonstrated ability to non-invasively and stimulate even the deepest areas of the brain in humans, and thus may have utility in directly modulating the subcortical drivers of exaggerated escape/ avoidance coping. Given this exciting possibility, the primary goal of this research is to determine if tFUS to subcortical neural mediators can be used to cause measurable changes in the downstream escape/ avoidance dispositions. Results will then inform the potential use of noninvasive tFUS stimulation as a precursor to evidence-based therapy to reduce risk of dropout and enhance outcomes.
- Conditions
- Anxiety Disorders
- Being tested
- Active transcranial focused ultrasound (tFUS), Sham transcranial focused ultrasound (tFUS)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Active transcranial focused ultrasound (tFUS); Device: Sham transcranial focused ultrasound (tFUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Secondary outcomes (8)
Change in speed to initiate avoidance behavior
Reaction time to initiate flight is measured in an experimental task in which participants change the size of pleasant or unpleasant images with a joystick. Reaction time measures behavioral tendency toward avoidance in the presence of unpleasant images or approach in the presence of pleasant images
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in Electroencephalography (EEG)-Assessed Contingent Negative Variation During Escape/ Avoidance Preparation
Brain electroencephalography (EEG) is measured non-invasively with sensors placed on top of the head during all pre/ post-stimulation experimental tasks. The Contingent Negative Variation (CNV) is an event-related potential measure of motor preparation processing that arises in S1-S2-type tasks.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in Electroencephalography (EEG)-Assessed N200 During Implicit Approach/ Avoid Bias Assessment
Brain electroencephalography (EEG) is measured non-invasively with sensors placed on top of the head during all pre/ post-stimulation experimental tasks. The N200 is an event-related potential measure of neural stimulus-response conflict that can be used to index the degree to which unpleasant stimuli facilitate avoidant behavior.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in Electroencephalography (EEG)-Assessed Theta-Band Power During Behavioral Tasks
Brain electroencephalography (EEG) is measured non-invasively with sensors placed on top of the head during all pre/ post-stimulation experimental tasks. Power in a theta frequency band is a measure of cognitive control that will be assayed in all behavioral tasks as a measure of task engagement changes
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in High-Frequency Heart Rate Variability/ Respiratory Sinus Arrhythmia
Heart rate and also respiration are measured during all pre/ post-stimulation experimental tasks. These measures can be combined to derive an index of the strength of vagal control over the heart (High-Frequency Heart Rate Variability/ Respiratory Sinus Arrhythmia) that reflects greater attentional control relative to stress (i.e., sympathetic) responding. This measure will be assayed in all tasks and in resting measurements conducted pre- and post-stimulation.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in Task-Based Heart Rate (Beats per Minute) Changes
Heart rate is measured during all pre/ post-stimulation experimental tasks. Task event-related changes in heart rate will be measured as an index of the strength of attentional orienting to all motivationally relevant cues
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in Task-Based Galvanic Skin Conductance
Skin conductance is measured during all pre/ post-stimulation experimental tasks from sensors placed on the hand. Skin conductance can be indexed to test for changes in sympathetic activation during escape/ avoidance preparation.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in State Anxiety During Session
State-level anxiety is measured throughout the experimental session using the State-Trait Anxiety Inventory - State Form. The State-Trait Anxiety Inventory - State Form uses 20 items querying anxiety symptom experience in the present moment to measure how anxiety fluctuates across the experimental session. The scale ranges from 20 to 80, with higher scores indicating higher state anxiety.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start20 May 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Sege, Medical University of South Carolina
- Investigators
- Christopher Sege, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273904
- Sponsor's protocol ID
- Pro00132631
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Escape in the Anxiety Disorder Spectrum: Targeting the Direct Neural Mediator Using Transcranial Focused Ultrasound
- ClinicalTrials.gov ID
- NCT06273904
- Acronym / sponsor ID
- Pro00132631
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Escape and avoidance are core targets of anxiety and related disorder treatment, but such behaviors also often persist even after reduction of reported symptoms or they keep an individual from engaging in treatment at all. Novel methods to directly target motive drivers of escape/ avoidance coping early in treatment are needed to improve retention and outcome especially for the 20% of individuals who do not benefit from and 40% who do not complete treatment. Basic science identifies multiple neural mediators of real-world escape and avoidance, and it suggests these mediators may not be directly or adequately targeted by current treatment techniques. Moreover, the direct neural mediators may be primarily subcortical and thus not be accessible to therapeutic technologies like transcranial magnetic stimulation that can only stimulate cortical areas. A novel technology called transcranial focused ultrasound (tFUS), meanwhile, has demonstrated ability to non-invasively and stimulate even the deepest areas of the brain in humans, and thus may have utility in directly modulating the subcortical drivers of exaggerated escape/ avoidance coping. Given this exciting possibility, the primary goal of this research is to determine if tFUS to subcortical neural mediators can be used to cause measurable changes in the downstream escape/ avoidance dispositions. Results will then inform the potential use of noninvasive tFUS stimulation as a precursor to evidence-based therapy to reduce risk of dropout and enhance outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Receiving Active Stimulation and Sham Stimulation on Separate Days (All Participants) | Experimental | Device: Active transcranial focused ultrasound (tFUS), Device: Sham transcranial focused ultrasound (tFUS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group Receiving Active Stimulation and Sham Stimulation on Separate Days (All Participants) |
| 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. | Device | Group Receiving Active Stimulation and Sham Stimulation on Separate Days (All Participants) |
Primary outcome
Change in Fear-Potentiated Startle Reflex
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
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.
8 secondary outcomes
Change in speed to initiate avoidance behavior
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in Electroencephalography (EEG)-Assessed Contingent Negative Variation During Escape/ Avoidance Preparation
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in Electroencephalography (EEG)-Assessed N200 During Implicit Approach/ Avoid Bias Assessment
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in Electroencephalography (EEG)-Assessed Theta-Band Power During Behavioral Tasks
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in High-Frequency Heart Rate Variability/ Respiratory Sinus Arrhythmia
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in Task-Based Heart Rate (Beats per Minute) Changes
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in Task-Based Galvanic Skin Conductance
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Change in State Anxiety During Session
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Sege, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active transcranial focused ultrasound (tFUS) in people with Anxiety Disorders, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher T Sege, PhD ((843) 501-1718, sege@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fear-Potentiated Startle Reflex (time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 10 minutes between assessments)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.