LIFUP for Treatment of Motor Deficits in Parkinson's Disease

NCT04593875 | Completed Results DMC FDA Device

• 1 other identifier: IRB#20-001901
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

LIFUP; Ultrasound

Outcome Measures

Primary Outcomes (4)

• Motor Assessment 1: 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. The total score for this assessment ranges from 0 to 108 points, with higher scores indicating higher severity.

  Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

• Motor Assessment 2: Finger Tapping (Score)

  This task, which is item 3.4 on the Unified Parkinson's Disease Rating Scale (UPDRS), asks participants to tap their index finger on their thumb ten times as big and as fast as possible. Participants scores on item 3.4 with standard UPDRS scoring criteria (on a scale of 0 to 4, where a higher score indicates more severe Parkinson's symptoms i.e. worse performance) will be assessed pre and post-LIFUP. The scores reported below are for the hand on the side with worse symptoms (i.e. the side that LIFUP is intended to primarily affect).

  Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

• Motor Assessment 2: Finger Tapping (Speed)

  This task, which is item 3.4 on the Unified Parkinson's Disease Rating Scale (UPDRS), asks participants to tap their index finger on their thumb ten times as big and as fast as possible. The speed of taps will be assessed pre and post-LIFUP. Speed is calculated as \[number of taps per second\] times \[average tap amplitude\], where tap amplitude is measured on a scale of 0.0-1.0 representing the percentage of finger extension between taps, where e.g. extension to a 90 degree angle between thumb and index finger = 1.0, extension to 45 degree angle = 0.5, etc. Higher speed indicates better performance. The speed values reported below are for the hand on the side with worse symptoms (i.e. the side that LIFUP is intended to primarily affect).

  Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

• 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

Secondary Outcomes (2)

• Difference in BOLD fMRI Signal Between on vs. Off Blocks

  During LIFUP (or sham) sonication on Day 1 and Day 15

• Perfusion Changes in Internal Globus Pallidus, External Globus Pallidus, and Putamen

  Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

Study Arms (2)

Active, then Sham

EXPERIMENTAL

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.

Device: Active LIFUP Treatment; Device: Sham LIFUP Treatment

Sham, then Active

EXPERIMENTAL

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.

Device: Active LIFUP Treatment; Device: Sham LIFUP Treatment

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.

Also known as: BX Pulsar 1002

Active, then Sham; Sham, then Active

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.

Active, then Sham; Sham, then Active

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's disease
• Age 18-85
• Fluent in the English language

You may not qualify if:

• Metal implants that are not MR compatible
• Neurological diagnosis other than Parkinson's
• Not fluent in the English language

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Natalie Rotstein
• Organization: University of California Los Angeles

tfus@mednet.ucla.edu

310-794-0077

Study Officials

• Susan Y Bookheimer, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All participants complete two identical in-person testing and LIFUP sessions. At one session, the device will be used with a gel pad that allows ultrasound to pass through, and at the other session, it will be used with a gel pad that blocks the ultrasound. The order of conditions is randomized and counterbalanced across participants. The two gel pads look identical beyond a label differentiating them, and neither the participants nor the person administering ultrasound will know whether sham or active is being administered at a given session.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be assigned to both study arms; the order in which they complete the arms will be randomized and counterbalanced. The two visits will be spaced apart by 2 weeks.

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 20, 2020
• Study Start: June 15, 2022
• Primary Completion: July 24, 2024
• Study Completion: July 31, 2024
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2024-08

Locations

US (1)