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Focused Ultrasound

Focused Ultrasound for Frailty (fUS-ARF Trial)

Phase < 1
Waitlist Available
Led By Sheldon Jordan, MD
Research Sponsored by Neurological Associates of West Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age eligibility requirements fall in a range from 60 to 95 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up final evaluation (8 weeks from baseline)
Awards & highlights

fUS-ARF Trial Summary

This trial is testing whether transcranial ultrasound is safe and effective in treating age-related frailty.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this is an early-stage trial focusing on transcranial ultrasound therapy, specific side effects aren't listed but may include discomfort at the site of application or headache due to sound waves.

fUS-ARF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 60 and 95 years old.

fUS-ARF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~final evaluation (8 weeks from baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and final evaluation (8 weeks from baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Frailty Scale (CFS)
Secondary outcome measures
Beck Anxiety Inventory (BAI)
Beck Depression Inventory (BDI-II)
Community Healthy Activities Model Program for Seniors (CHAMPS)
+5 more

fUS-ARF Trial Design

1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Focused Ultrasound
2012
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Neurological Associates of West Los AngelesLead Sponsor
25 Previous Clinical Trials
3,910 Total Patients Enrolled
1 Trials studying Frailty
100 Patients Enrolled for Frailty
Sheldon Jordan, MDPrincipal InvestigatorNeurological Associates - The Interventional Group
12 Previous Clinical Trials
2,540 Total Patients Enrolled

Media Library

Transcranial Ultrasound (Focused Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT04770350 — Phase < 1
Frailty Research Study Groups: Experimental
Frailty Clinical Trial 2023: Transcranial Ultrasound Highlights & Side Effects. Trial Name: NCT04770350 — Phase < 1
Transcranial Ultrasound (Focused Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04770350 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to join this medical experiment?

"This clinical trial seeks 50 frail individuals in the age bracket between 45 and 95 years old, with a lower eligibility threshold of 60. Qualifying patients must have been clinically appraised as exhibiting signs of frailty (outside of any concurrent condition) and be rated 3 to 7 on the CSHA Clinical Frailty Scale by their physician."

Answered by AI

Is the age range for this research limited to those over 25 years?

"According to the trial's eligibility requirements, participants must lie within 45 and 95 years old. Additionally, there are 7 studies for minors under 18 and 371 clinical trials dedicated to patients aged 65 or above."

Answered by AI

Are there any vacancies remaining for this medical investigation?

"According to the clinicaltrials.gov database, this medical study is not accepting patients presently. It was uploaded on September 1st 2023 and last revised on September 26th 2022. Although enrollment for this trial has been suspended, there are still 380 other trials open for recruitment of participants at present."

Answered by AI

Who else is applying?

What site did they apply to?
Neurological Associates of West Los Angeles
What portion of applicants met pre-screening criteria?
Did not meet criteria
~21 spots leftby Sep 2024