Parkinson DiseaseLIFUP PDNCT04593875

LIFUP for Treatment of Motor Deficits in Parkinson's Disease

A study testing Active LIFUP Treatment in people with Parkinson Disease, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Parkinson Disease
What is being tested?: Active LIFUP Treatment
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 15 Jun 2022to 31 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, Los Angeles
Los Angeles, California, 90095

Other trials in United States

About this study

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

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.

Read the 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
Being tested: Active LIFUP Treatment, Sham LIFUP Treatment
Keywords: LIFUP, Ultrasound
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active LIFUP TreatmentDevice
Also called BX Pulsar 1002
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 TreatmentDevice
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 groups in NCT04593875
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Active LIFUP Treatment; Device: Sham LIFUP Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

Secondary outcomes (2)

Difference in BOLD fMRI Signal Between on vs. Off Blocks
BOLD data will be collected in real-time during the ultrasound sonication, which occurs in interleaved 30 second "on" and "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. Tabular data reported here represents the difference in BOLD activation between on and off conditions in the internal globus pallidus on the targeted side of the brain, calculated as the mean BOLD activation while LIFUP is on minus mean activation when it is off.
Measured: During LIFUP (or sham) sonication on Day 1 and Day 15
Perfusion Changes in Internal Globus Pallidus, External Globus Pallidus, and Putamen
Arterial spin labeling data will be collected before and after sonication. Analyses will assess the statistical relationship between perfusion in the targeted internal globus pallidus, external globus pallidus, and putamen pre- and post-sonication in a within-subject repeated measures design.
Measured: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 202231 Jul 2024

First posted20 Oct 2020
Study start15 Jun 2022
Primary completion24 Jul 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 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.
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04593875
Sponsor's protocol ID: IRB#20-001901
Acronym: LIFUP PD
Status last verified: Aug 2024
First submitted: 3 Oct 2020
Last updated: 4 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Low-Intensity Focused Ultrasound Pulsation for Treatment of Motor Deficits in Parkinson's Disease
ClinicalTrials.gov ID: NCT04593875
Acronym / sponsor ID: LIFUP PD / IRB#20-001901
Conditions: Parkinson Disease
Keywords: LIFUP, Ultrasound
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Study start: 15 Jun 2022 (actual)
Primary completion: 24 Jul 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 20 Oct 2020 (actual)
Results: Posted 4 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Active, then Sham	Experimental	Device: Active LIFUP Treatment, Device: Sham LIFUP TreatmentActive 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	Experimental	Device: Active LIFUP Treatment, Device: Sham LIFUP TreatmentSham 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active LIFUP TreatmentAlso: BX Pulsar 1002Low 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	Active, then Sham, Sham, then Active
Sham LIFUP TreatmentThe 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.	Device	Active, then Sham, Sham, then Active

Primary outcome

Motor Assessment 1: Unified Parkinson Disease Rating Scale (UPDRS) Section 3
Time frame: 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.
Motor Assessment 2: Finger Tapping (Score)
Time frame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
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).
Motor Assessment 2: Finger Tapping (Speed)
Time frame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
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).
Motor Assessment 2: 9-Hole Pegboard Dexterity Test
Time frame: 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.

2 secondary outcomes

Difference in BOLD fMRI Signal Between on vs. Off Blocks
Time frame: During LIFUP (or sham) sonication on Day 1 and Day 15
Perfusion Changes in Internal Globus Pallidus, External Globus Pallidus, and Putamen
Time frame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

Results and safety

Results posted to the registry on 4 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active, Then Sham	15	15
Sham, Then Active	16	16

Primary outcome: Motor Assessment 1: Unified Parkinson Disease Rating Scale (UPDRS) Section 3

Time frame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15. Mean (Standard Deviation). Unit: score on a scale

Measure	Active LIFUP Session n = 29	Sham LIFUP Session n = 29
Pre-LIFUP	37.24 (9.91)	35.14 (8.28)
Post-LIFUP	36.93 (9.54)	34.21 (9.43)

Population analysed: One participant was not included in motor symptom analyses due to extreme motor symptom fluctuations at baseline confounding measurement of LIFUP-related changes

Primary outcome: Motor Assessment 2: Finger Tapping (Score)

Time frame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15. Mean (Standard Deviation). Unit: score on a scale

Measure	Active LIFUP Session n = 29	Sham LIFUP Session n = 29
Pre-LIFUP Score	1.48 (0.829)	1.45 (0.936)
Post-LIFUP Score	1.66 (0.974)	1.34 (0.948)

Population analysed: One participant was not included in motor symptom analyses due to extreme motor symptom fluctuations at baseline confounding measurement of LIFUP-related changes

Primary outcome: Motor Assessment 2: Finger Tapping (Speed)

Time frame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15. Mean (Standard Deviation). Unit: tap amplitude per second

Measure	Active LIFUP Session n = 29	Sham LIFUP Session n = 29
Pre-LIFUP Speed	1.81 (0.75)	1.72 (0.74)
Post-LIFUP Speed	1.70 (0.75)	1.94 (0.80)

Primary outcome: Motor Assessment 2: 9-Hole Pegboard Dexterity Test

Time frame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15. Mean (Standard Deviation). Unit: Seconds

Measure	Active LIFUP Session n = 29	Sham LIFUP Session n = 29
Pre-LIFUP (Hand on side with more severe symptoms)	23.87 (9.44)	23.94 (9.61)
Post-LIFUP (Hand on side with more severe symptoms)	23.49 (7.54)	23.12 (7.34)
Pre-LIFUP (Hand on side with less severe symptoms)	21.04 (6.26)	20.73 (7.50)
Post-LIFUP (Hand on side with less severe symptoms)	20.46 (5.79)	20.12 (4.40)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected 2, 4, and 7 days after each in-person session, and the two in-person sessions were two weeks apart. As a result, depending on whether participants received active then sham or sham then active, adverse event data were collected for either one week or three weeks after the active intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active LIFUP Session	0 of 30 (0%)	5 of 30 (16.7%)	0 of 30
Sham LIFUP Session	0 of 31 (0%)	6 of 31 (19.4%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Y Bookheimer, Ph.D. principal investigator

University of California, Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active LIFUP Treatment in people with Parkinson Disease, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04593875.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.