NCT04770350

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
2.5 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

1.1 years

First QC Date

February 22, 2021

Last Update Submit

September 26, 2022

Conditions

FrailtyAging

Outcome Measures

Primary Outcomes (2)

  • Clinical Frailty Scale (CFS)

    The CFS is a 9-point scoring guide for physicians to use upon clinical appraisal of frailty-related symptoms. The lowest rating is 1 ("Very Fit") and the highest rating is 9 ("Terminally Ill"). The range of acceptable ratings for screened participants is from 3 ("Managing Well") to 7 ("Severely Frail").

    Baseline

  • Clinical Frailty Scale (CFS)

    The CFS is a 9-point scoring guide for physicians to use upon clinical appraisal of frailty-related symptoms. The lowest rating is 1 ("Very Fit") and the highest rating is 9 ("Terminally Ill"). The range of acceptable ratings for screened participants is from 3 ("Managing Well") to 7 ("Severely Frail"). Scoring on the CFS will be noted as significant for those who improve by at least one level.

    Final Evaluation (8 weeks from baseline)

Secondary Outcomes (15)

  • Short Physical Performance Battery (SPPB)

    Baseline

  • Short Physical Performance Battery (SPPB)

    Final Evaluation (8 weeks from baseline)

  • Multidimensional Fatigue Inventory (MFI)

    Baseline

  • Multidimensional Fatigue Inventory (MFI)

    Final Evaluation (8 weeks from baseline)

  • Montreal Cognitive Assessment (MoCA)

    Baseline

  • +10 more secondary outcomes

Study Arms (1)

Experimental

EXPERIMENTAL

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.

Device: Focused Ultrasound

Interventions

Focused UltrasoundDEVICE

The DWL Doppler ultrasound device enables visual and auditory waveform confirmation of the middle cerebral artery, and optical tracking technology (e.g., AntNeuro Visor2™ system) may be used in tandem with the Brainsonix ultrasound device to track a patient's brain in virtual space as well as their physical location, thereby ensuring accurate placement.

Experimental

Eligibility Criteria

Age45 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurological Associates of West Los Angeles

Santa Monica, California, 90403, United States

Location

Related Publications (8)

  • Tompkins BA, DiFede DL, Khan A, Landin AM, Schulman IH, Pujol MV, Heldman AW, Miki R, Goldschmidt-Clermont PJ, Goldstein BJ, Mushtaq M, Levis-Dusseau S, Byrnes JJ, Lowery M, Natsumeda M, Delgado C, Saltzman R, Vidro-Casiano M, Da Fonseca M, Golpanian S, Premer C, Medina A, Valasaki K, Florea V, Anderson E, El-Khorazaty J, Mendizabal A, Green G, Oliva AA, Hare JM. Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Gerontol A Biol Sci Med Sci. 2017 Oct 12;72(11):1513-1522. doi: 10.1093/gerona/glx137.

    PMID: 28977399BACKGROUND

  • Zhang Y, Kim MS, Jia B, Yan J, Zuniga-Hertz JP, Han C, Cai D. Hypothalamic stem cells control ageing speed partly through exosomal miRNAs. Nature. 2017 Aug 3;548(7665):52-57. doi: 10.1038/nature23282. Epub 2017 Jul 26.

    PMID: 28746310BACKGROUND

  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PMID: 23395245BACKGROUND

  • Song X, Mitnitski A, Rockwood K. Prevalence and 10-year outcomes of frailty in older adults in relation to deficit accumulation. J Am Geriatr Soc. 2010 Apr;58(4):681-7. doi: 10.1111/j.1532-5415.2010.02764.x. Epub 2010 Mar 22.

    PMID: 20345864BACKGROUND

  • Lopez-Otin C, Blasco MA, Partridge L, Serrano M, Kroemer G. The hallmarks of aging. Cell. 2013 Jun 6;153(6):1194-217. doi: 10.1016/j.cell.2013.05.039.

    PMID: 23746838BACKGROUND

  • Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

    PMID: 16129869BACKGROUND

  • Juma S, Taabazuing MM, Montero-Odasso M. Clinical Frailty Scale in an Acute Medicine Unit: a Simple Tool That Predicts Length of Stay. Can Geriatr J. 2016 Jun 29;19(2):34-9. doi: 10.5770/cgj.19.196. eCollection 2016 Jun.

    PMID: 27403211BACKGROUND

  • Islam A, Muir-Hunter SW, Speechley M, Montero-Odasso M. Facilitating Frailty Identification: Comparison of Two Methods among Community-Dwelling Order Adults. J Frailty Aging. 2014;3(4):216-21. doi: 10.14283/jfa.2014.27.

    PMID: 27048860BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sheldon Jordan, MD

    Neurological Associates - The Interventional Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

September 1, 2023

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)