LIFUP for Treatment of Motor Deficits in Parkinson's Disease

Not Applicable

Recruiting

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Active, then Sham	Active LIFUP Treatment	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.
Active, then Sham	Sham LIFUP Treatment	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.
Sham, then Active	Active LIFUP Treatment	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.
Sham, then Active	Sham LIFUP Treatment	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 Measures

Name	Time	Method
Motor Assessment 1: Finger Tapping	Pre-LIFUP and Post-LIFUP at Day 1 and Day 15	The participant will tap their index finger rhythmically on their thumb. Analysis will compare the average frequency, velocity, and amplitude of taps to quantify motor performance improvements.
Motor Assessment 2: 9-Hole Pegboard Dexterity Test	Pre-LIFUP and Post-LIFUP at Day 1 and Day 15	The participant will place and remove nine plastic pegs into a plastic pegboard. Scores are recorded as time in seconds that it takes the participant to complete the task with each hand. Analysis will compare pre- and post-treatment scores to quantify motor performance improvements.
Motor Assessment 3: Unified Parkinson Disease Rating Scale (UPDRS) Section 3	Pre-LIFUP and Post-LIFUP at Day 1 and Day 15	The participant will complete a 18-item comprehensive motor assessment that assesses elements of motor function including tremor, bradykinesia, and gait. The total score for this assessment ranges from 0 to 108 points, with higher scores indicating higher severity.

Secondary Outcome Measures

Name	Time	Method
BOLD fMRI Signal in Internal Globus Pallidus	During LIFUP (or sham) sonication on Day 1 and Day 15	BOLD data will be collected in real-time during the ultrasound sonication, which occurs in on-off blocks. Analyses will assess the statistical relationship between BOLD signal in the brain and the time series (on vs off) of the ultrasound sonication.
Perfusion throughout Brain	Pre-LIFUP and Post-LIFUP at Day 1 and Day 15	Arterial spin labeling data will be collected before and after sonication. Analyses will assess the statistical relationship between perfusion throughout the brain pre- and post-sonication in a within-subject repeated measures design.

Locations (1): University of California, Los Angeles
🇺🇸
Los Angeles, California, United States