LIFUP for Treatment of Motor Deficits in Parkinson's Disease
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of California, Los Angeles
- Study ID
- NCT04593875
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Active LIFUP Treatment — DEVICELow intensity focused ultrasound pulsation will be administered to the internal globus pallidus in 20 sonications at 650kHz, ispta.3 720mW/cm, pulse repetition frequency 100Hz, duty cycle 5%, duration 30s with 30s spacing between sonications. For active LIFUP, the device will be used with a gel pad that allows the ultrasound to pass through.
- Sham LIFUP Treatment — DEVICEThe device will be aimed at the internal globus pallidus and turned on with the same settings as the active condition; however, in this case, the device will be used with a gel pad that blocks the ultrasound from passing through, such that no ultrasound is actually being administered to the brain.
Study Details
The study will test the feasibility of using Low Intensity Focused Ultrasound Pulsation (LIFUP) to treat motor symptoms in Parkinson's Disease (PD). LIFUP is a new technique that can increase brain activity in highly specific target areas and is MRI compatible. Thus, in real-time, it is possible to directly observe how LIFUP changes the brain areas important in PD by measuring its effects on brain activity, blood flow, and brain connectivity. If successful, this research will mark the first step towards a novel, non-invasive, non-medication treatment for PD.
Key Dates
- Start date
- Jun 15, 2022
- Status verified
- Aug 2024
- Primary completion
- Jul 24, 2024
- Completion
- Jul 31, 2024
Study Design
- Enrollment
- 31 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Active, then ShamActive Low intensity focused ultrasound pulsation (LIFUP) will be administered to the internal globus pallidus while participants are in the MRI scanner. Then, 2 weeks later, sham LIFUP will be administered.
- Experimental: Sham, then ActiveSham low intensity focused ultrasound pulsation (LIFUP) will be administered while participants are in the MRI scanner. Then, 2 weeks later, active LIFUP will be administered to the internal globus pallidus.
Primary Outcome Measure
Motor Assessment 1: Unified Parkinson Disease Rating Scale (UPDRS) Section 3 [ Time Frame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | - |
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