Clinical trial NCT04770350: Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty
Official title: Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Frailty
Aging
Lead sponsor: Neurological Associates of West Los Angeles
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Clinical Frailty Scale (CFS)
timeFrame: Baseline
measure: Clinical Frailty Scale (CFS)
timeFrame: Final Evaluation (8 weeks from baseline)
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline
measure: Short Physical Performance Battery (SPPB)
timeFrame: Final Evaluation (8 weeks from baseline)
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Final Evaluation (8 weeks from baseline)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Final Evaluation (8 weeks from baseline)
measure: Beck Depression Inventory (BDI-II)
timeFrame: Baseline
measure: Beck Depression Inventory (BDI-II)
timeFrame: Final Evaluation (8 weeks from baseline)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline
measure: Beck Anxiety Inventory (BAI)
timeFrame: Final Evaluation (8 weeks from baseline)
measure: Community Healthy Activities Model Program for Seniors (CHAMPS)
timeFrame: Baseline
measure: Community Healthy Activities Model Program for Seniors (CHAMPS)
timeFrame: Final Evaluation (8 weeks from baseline)
measure: Grip Strength (Dynamometer Performance)
timeFrame: Baseline
measure: Grip Strength (Dynamometer Performance)
timeFrame: Final Evaluation (8 weeks from baseline)
measure: Global Rating of Change (GRC)
timeFrame: Final Evaluation (8 weeks from baseline)
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Neurological Associates of West Los Angeles
state: California
Study officials:
affiliation: Neurological Associates - The Interventional Group
name: Sheldon Jordan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.