Focused Ultrasound for Frailty

(fUS-ARF Trial)

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Neurological Associates of West Los Angeles

Disqualifiers: Pregnancy, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sheldon Jordan, MD

Principal Investigator

Neurological Associates - The Interventional Group

Eligibility Criteria

This study is for people aged 60-95 showing signs of frailty but not from another condition, scoring between 3 and 7 on the Frailty Scale. They must have a brain MRI with hypothalamus volume measured. It's not for those who can't lie still, are pregnant or breastfeeding, have terminal illness, can't consent, or have scalp issues.

Inclusion Criteria

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)

I have had an MRI of my brain that measured the size of my hypothalamus.

I am between 60 and 95 years old.

Exclusion Criteria

Pregnancy, women who may become pregnant or are breastfeeding

I have a scalp rash or open wounds on my scalp.

I am unable to understand and give consent for treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 sessions of transcranial ultrasound treatment, each lasting 10 to 30 minutes

8 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Weekly follow-ups

Treatment Details

Interventions

• Transcranial Ultrasound

Trial Overview The trial tests transcranial ultrasound as a treatment for age-related frailty. This Phase I open label study aims to assess its tolerability over time and potential effectiveness in improving symptoms of frailty.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

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.

Transcranial Ultrasound is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Doppler Ultrasonography for:

• Sickle Cell Disease
• Cerebral Ischemia
• Detection of Right-to-Left Shunts
• Subarachnoid Hemorrhage
• Brain Death
• Periprocedural or Surgical Monitoring

Approved in European Union as Transcranial Doppler Ultrasonography for:

• Sickle Cell Disease
• Cerebral Ischemia
• Detection of Right-to-Left Shunts
• Subarachnoid Hemorrhage
• Brain Death
• Periprocedural or Surgical Monitoring

Who Is Running the Clinical Trial?

Neurological Associates of West Los Angeles

Lead Sponsor

Trials

26

Recruited

4,000+