Open Label Study for the Use of Transcranial Ultrasound for Treatment of Age-Related Frailty
NCT04770350 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2022-09-28
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.
Conditions
- Frailty
- Aging
Interventions
- DEVICE
-
Focused Ultrasound
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.
Sponsors & Collaborators
-
Neurological Associates of West Los Angeles
lead OTHER
Principal Investigators
-
Sheldon Jordan, MD · Neurological Associates - The Interventional Group
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 45 Years
- Max Age
- 95 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2024-09-30
- Completion
- 2024-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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