Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-01 @ 12:40 PM
Study NCT ID:
NCT04770350
Status:
UNKNOWN
Last Update Posted:
2022-09-28
First Post:
2021-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
Study Overview
Official Title:
Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ENROLLING_BY_INVITATION
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:
False
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?: