NCT04593875

LIFUP for Treatment of Motor Deficits in Parkinson's Disease

Low-Intensity Focused Ultrasound Pulsation for Treatment of Motor Deficits in Parkinson's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This trial is a proof-of-concept, proof-of-mechanism study of a novel neuromodulation technology - LIFUP - to treat motor symptoms in PD. Much like Deep Brain Stimulation, LIFUP can be focused on deep brain structures with high spatial accuracy, including those implicated in PD; however, it can do so non-invasively. Other non-invasive neuromodulation tools such as Transcranial Magnetic Stimulation can only target surface brain structures and are not optimal PD treatment tools. This study will test this new technology in 30 participants with PD during simultaneous resting state functional MRI, and collect pre- and post-LIFUP functional MRI, arterial spin labeling, motor performance data, and behavioral data, in a double-blind crossover trial to determine whether LIFUP: 1) will improve motor symptoms during and after treatment; 2) can modulate neural activity in the target brain region important for PD, the internal globus pallidus; and 3) enhance cortico-striatal motor circuit connectivity. All participants in this study will receive active ultrasound at one of the two in-person sessions and sham at the other.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Active LIFUP Treatment	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.
DEVICE	Sham LIFUP Treatment	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.

Timeline

• Start date: 2022-06-15
• Primary completion: 2024-07-24
• Completion: 2024-07-31
• First posted: 2020-10-20
• Last updated: 2026-02-04
• Results posted: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study