Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013384
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-08-22
Brief Title:
Low-Intensity Focused Ultrasound for Treatment-Resistant Depression
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Clinical Feasibility of Low Intensity Focused Ultrasound Pulsation for the Treatment of Treatment Resistant Major Depressive Disorder
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Investigators are proposing to demonstrate safety and efficacy of LIFUP for treatment resistant major depressive disorder in a ten-patient pilot study LIFUP is an emerging treatment with the advantage of being able to target subcortical transcranial targets which may have superior efficacy or a shorter treatment course compared to other available treatments such as transcranial magnetic stimulation This study will investigate the effect of this stimulation on the left subgenual cingulate cortex a highly connected node in the depression network that is correlated with clinical symptomatology
Detailed Description:
The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment low intensity focused ultrasound pulsation LIFUP for treatment resistant depression TRD Participants will receive either LIFUP or sham stimulation with crossover of sham participants into the treatment group halfway through the treatment course The initial visit will involve consent and an MRI scan followed by several more either active or sham treatments outside of the MRI environment delivered over the course of two days over one week Response and potential side effects will be monitored pre- and post- each treatment along with one week and one month follow-up assessments
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?:
None
Is an FDA AA801 Violation?:
None