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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04770350
Study type Interventional
Source Neurological Associates of West Los Angeles
Contact
Status Enrolling by invitation
Phase Early Phase 1
Start date September 1, 2023
Completion date December 31, 2024

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