Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty (fUS-ARF)

Neurological Associates of West Los Angeles

Status and phase: Invitation-only; Early Phase 1

Conditions: Aging; Frailty

Treatments: Device: Focused Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04770350

fUS-Frailty

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 45 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Experimental

Experimental group

Description:

Participants will undergo ten to thirty minutes of transcranial ultrasound treatment. The sanitation device will be aimed at the hypothalamus. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space.

Treatment:

Device: Focused Ultrasound