Status:
UNKNOWN
Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty
Lead Sponsor:
Neurological Associates of West Los Angeles
Conditions:
Frailty
Aging
Eligibility:
All Genders
45-95 years
Phase:
EARLY_PHASE1
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 thi...
Eligibility Criteria
Inclusion
- Age eligibility requirements fall in a range from 60 to 95 years of age
- Clinical appraisal by physician indicating signs of frailty (apart from a co-occuring condition), scoring 3\<x\<7 as denoted by the CSHA Clinical Frailty Scale (Rockwood, Song, MacKnight, et al, 2005; Golpanian, DiFede, Pujol, et al., 2016)
- MRI of the brain including volume measurement of the hypothalamus
Exclusion
- Subjects unable to give informed consent
- Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
- Pregnancy, women who may become pregnant or are breastfeeding
- Advanced terminal illness
- Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04770350
Start Date
September 1 2023
End Date
December 31 2024
Last Update
September 28 2022
Active Locations (1)
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1
Neurological Associates of West Los Angeles
Santa Monica, California, United States, 90403