Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04770350
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-09-28
First Post:
2021-02-22
Brief Title:
Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty
Sponsor:
Neurological Associates of West Los Angeles
Organization:
Neurological Associates of West Los Angeles
Study Overview
Official Title:
Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2022-09
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:
fUS-ARF
Brief Summary:
The purpose of this Phase I open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with age-related frailty
Detailed Description:
This study is designed to evaluate the safety and efficacy of focused ultrasound in patients with age-related frailty characterized by reduced physical and immunological functioning The safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using focused ultrasound Adverse events will be noted whenever they occur but will be recorded at the time of the procedure and throughout routine follow-ups which will persist weekly throughout the duration of the active study protocol Patients deemed potentially appropriate candidates for focused ultrasound therapy will be treated with 8 sessions of transcranial ultrasound each of which consists of 10 to 30 minutes of active administration Clinical and safety outcome measures will be obtained throughout and after completion of the study protocol
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