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 — DEVICE
    Low 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 — DEVICE
    The 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 Sham
    Active 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 Active
    Sham 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)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095-

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