Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Frailty
- Sponsor
- Neurological Associates of West Los Angeles
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Clinical Frailty Scale (CFS)
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
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)
Outcomes
Primary Outcomes
Clinical Frailty Scale (CFS)
Time Frame: Final Evaluation (8 weeks from baseline)
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.
Secondary Outcomes
- Multidimensional Fatigue Inventory (MFI)(Final Evaluation (8 weeks from baseline))
- Montreal Cognitive Assessment (MoCA)(Final Evaluation (8 weeks from baseline))
- Beck Depression Inventory (BDI-II)(Final Evaluation (8 weeks from baseline))
- Beck Anxiety Inventory (BAI)(Final Evaluation (8 weeks from baseline))
- Grip Strength (Dynamometer Performance)(Final Evaluation (8 weeks from baseline))
- Short Physical Performance Battery (SPPB)(Final Evaluation (8 weeks from baseline))
- Community Healthy Activities Model Program for Seniors (CHAMPS)(Final Evaluation (8 weeks from baseline))
- Global Rating of Change (GRC)(Final Evaluation (8 weeks from baseline))