Using focused ultrasound to help treat anxiety disorders
Modulating Escape in the Anxiety Disorder Spectrum: Targeting the Direct Neural Mediator Using Transcranial Focused Ultrasound
This study is testing whether focused ultrasound can help people with anxiety by changing how their brain works during emotional tasks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06273904 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of transcranial focused ultrasound (tFUS) as a non-invasive method to modulate brain activity in individuals with anxiety disorders. Participants will undergo three visits where they will complete interviews and tasks involving emotional stimuli while their brain activity is monitored using MRI. The primary goal is to assess whether tFUS can effectively target subcortical brain areas associated with escape and avoidance behaviors, potentially improving treatment outcomes for those struggling with anxiety. The study aims to provide insights into the efficacy of tFUS as a precursor to traditional therapeutic interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who meet the criteria for an anxiety disorder and are currently seeking mental health treatment.
Not a fit: Patients with severe substance use disorders, psychotic disorders, or neurological conditions that contraindicate brain stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a novel, non-invasive treatment option for individuals with anxiety disorders, enhancing their coping mechanisms and treatment retention.
How similar studies have performed: While the use of tFUS is a relatively novel approach, preliminary studies suggest potential efficacy in modulating brain activity, though this specific application for anxiety disorders is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Christopher Sege, PhD — Medical University of South Carolina
- Study coordinator: Christopher T Sege, PhD
- Email: sege@musc.edu
- Phone: (843) 501-1718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.