Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty

Status unconfirmed · Early Phase 1

Conditions studied: Frailty, Aging

In brief

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.

Key facts

Study ID

NCT04770350

Run by

Neurological Associates of West Los Angeles

People needed

50

Starts

2023-09-01

Expected to finish

2024-12-31

Last updated by the study team

2022-09-28

Who can join

Age: 45 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Neurological Associates of West Los Angeles — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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