Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273904
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-02-13
Brief Title:
Modulating Escape Using Focused Ultrasound
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Modulating Escape in the Anxiety Disorder Spectrum Targeting the Direct Neural Mediator Using Transcranial Focused Ultrasound
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None