LIFUP for Treatment of Motor Deficits in Parkinson's Disease

Parkinson Disease Clinical Trial

— LIFUP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593875
• Other study ID #: CTP-LIFUP-PD-01
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: University of California, Los Angeles
• Contact: Taylor P Kuhn, Ph.D.
• Phone: 310-825-2631
• Email: tkuhn[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of Parkinson's disease

2. Age 18-85

3. Fluent in the English language

Exclusion Criteria:

1. Metal implants that are not MR compatible

2. Neurological diagnosis other than Parkinson's

3. Not fluent in the English language

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Assessment 1: Finger Tapping	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.	Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
Primary	Motor Assessment 2: 9-Hole Pegboard Dexterity Test	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.	Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
Primary	Motor Assessment 3: Unified Parkinson Disease Rating Scale (UPDRS) Section 3	The participant will complete a 18-item comprehensive motor assessment that assesses elements of motor function including tremor, bradykinesia, and gait.	Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
Secondary	BOLD fMRI Signal in Internal Globus Pallidus	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.	During LIFUP (or sham) sonication on Day 1 and Day 15
Secondary	Perfusion throughout Brain	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.	Pre-LIFUP and Post-LIFUP at Day 1 and Day 15