RECRUITING

Modulating Escape Using Focused Ultrasound

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Modulating Escape in the Anxiety Disorder Spectrum: Targeting the Direct Neural Mediator Using Transcranial Focused Ultrasound

Quick Facts

Study Start:2024-05-20
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06273904

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-65 y.o.
  2. * 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
  3. * Is currently seeking mental health treatment
  4. * Is able to read consent document and provide informed consent.
  5. * English is a first or primary fluent language.
  1. * 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)
  2. * Lifetime diagnosis of psychotic disorder or bipolar mania
  3. * Presence of neurological disorder that contraindicates brain stimulation or neurophysiological recording: Seizure disorder
  4. * Lifetime history of traumatic brain injury with loss of consciousness
  5. * Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)
  6. * Presence of other medical disorder that would make it too uncomfortable to sit or lie still for long recording periods
  7. * Presence of standard contraindications for magnetic resonance imaging
  8. * Metal in the body
  9. * Currently pregnant
  10. * Claustrophobia
  11. * Significant sensitivity to noise
  12. * Medical conditions or treatments that lower seizure threshold
  13. * History of severe brain injury
  14. * History of seizures/ epilepsy
  15. * Currently taking anticholinergic mediation, neuroleptic medication, or sedative/ hypnotic medication
  16. * Currently taking chronic opiate medications or substances
  17. * Currently taking naltrexone

Contacts and Locations

Study Contact

Christopher T Sege, PhD
CONTACT
(843) 501-1718
sege@musc.edu

Principal Investigator

Christopher Sege, PhD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Christopher Sege, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-20
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-05-20
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Anxiety Disorders