Trial Outcomes & Findings for LIFUP for Treatment of Motor Deficits in Parkinson's Disease (NCT NCT04593875)
NCT ID: NCT04593875
Last Updated: 2026-02-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
Results posted on
2026-02-04
Participant Flow
Participant milestones
| Measure |
Active, Then Sham
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 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.
|
Sham, Then Active
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.
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.
|
|---|---|---|
|
First Intervention (1 day)
STARTED
|
15
|
16
|
|
First Intervention (1 day)
Started
|
15
|
16
|
|
First Intervention (1 day)
COMPLETED
|
15
|
16
|
|
First Intervention (1 day)
NOT COMPLETED
|
0
|
0
|
|
Washout / Follow-Up (2 weeks)
STARTED
|
15
|
16
|
|
Washout / Follow-Up (2 weeks)
COMPLETED
|
15
|
15
|
|
Washout / Follow-Up (2 weeks)
NOT COMPLETED
|
0
|
1
|
|
Second Intervention (1 day)
STARTED
|
15
|
15
|
|
Second Intervention (1 day)
COMPLETED
|
15
|
15
|
|
Second Intervention (1 day)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Follow-Up (1 week)
STARTED
|
15
|
15
|
|
Second Intervention Follow-Up (1 week)
COMPLETED
|
15
|
15
|
|
Second Intervention Follow-Up (1 week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Active, Then Sham
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 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.
|
Sham, Then Active
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.
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.
|
|---|---|---|
|
Washout / Follow-Up (2 weeks)
Withdrawn by investigator after completing first intervention follow-up
|
0
|
1
|
Baseline Characteristics
LIFUP for Treatment of Motor Deficits in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Active, Then Sham
n=15 Participants
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 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.
|
Sham, Then Active
n=16 Participants
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.
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 9.5 • n=25 Participants
|
66.8 years
STANDARD_DEVIATION 8.0 • n=26 Participants
|
66.1 years
STANDARD_DEVIATION 8.7 • n=51 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=25 Participants
|
5 Participants
n=26 Participants
|
10 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=25 Participants
|
11 Participants
n=26 Participants
|
21 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=25 Participants
|
16 Participants
n=26 Participants
|
29 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
2 Participants
n=26 Participants
|
2 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=25 Participants
|
14 Participants
n=26 Participants
|
29 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15Population: One participant was not included in motor symptom analyses due to extreme motor symptom fluctuations at baseline confounding measurement of LIFUP-related changes
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.
Outcome measures
| Measure |
Active LIFUP Session
n=29 Participants
LIFUP will be administered to the internal globus pallidus on the side of the brain contralateral to the side of the body with worse symptoms. The side of the brain contralateral to worse symptoms is being targeted because the left hemisphere of the brain primarily controls right side motor function and vice versa.
The LIFUP protocol will entail 20 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
Sham LIFUP Session
n=29 Participants
LIFUP will be administered with an identical protocol to the active session; however, the gel pad used during the sham session blocks the ultrasound such that none actually reaches the head.
|
|---|---|---|
|
Motor Assessment 1: Unified Parkinson Disease Rating Scale (UPDRS) Section 3
Pre-LIFUP
|
37.24 score on a scale
Standard Deviation 9.91
|
35.14 score on a scale
Standard Deviation 8.28
|
|
Motor Assessment 1: Unified Parkinson Disease Rating Scale (UPDRS) Section 3
Post-LIFUP
|
36.93 score on a scale
Standard Deviation 9.54
|
34.21 score on a scale
Standard Deviation 9.43
|
PRIMARY outcome
Timeframe: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15Population: One participant was not included in motor symptom analyses due to extreme motor symptom fluctuations at baseline confounding measurement of LIFUP-related changes
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).
Outcome measures
| Measure |
Active LIFUP Session
n=29 Participants
LIFUP will be administered to the internal globus pallidus on the side of the brain contralateral to the side of the body with worse symptoms. The side of the brain contralateral to worse symptoms is being targeted because the left hemisphere of the brain primarily controls right side motor function and vice versa.
The LIFUP protocol will entail 20 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
Sham LIFUP Session
n=29 Participants
LIFUP will be administered with an identical protocol to the active session; however, the gel pad used during the sham session blocks the ultrasound such that none actually reaches the head.
|
|---|---|---|
|
Motor Assessment 2: Finger Tapping (Score)
Pre-LIFUP Score
|
1.48 score on a scale
Standard Deviation 0.829
|
1.45 score on a scale
Standard Deviation 0.936
|
|
Motor Assessment 2: Finger Tapping (Score)
Post-LIFUP Score
|
1.66 score on a scale
Standard Deviation 0.974
|
1.34 score on a scale
Standard Deviation 0.948
|
PRIMARY outcome
Timeframe: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15This 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).
Outcome measures
| Measure |
Active LIFUP Session
n=29 Participants
LIFUP will be administered to the internal globus pallidus on the side of the brain contralateral to the side of the body with worse symptoms. The side of the brain contralateral to worse symptoms is being targeted because the left hemisphere of the brain primarily controls right side motor function and vice versa.
The LIFUP protocol will entail 20 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
Sham LIFUP Session
n=29 Participants
LIFUP will be administered with an identical protocol to the active session; however, the gel pad used during the sham session blocks the ultrasound such that none actually reaches the head.
|
|---|---|---|
|
Motor Assessment 2: Finger Tapping (Speed)
Pre-LIFUP Speed
|
1.81 tap amplitude per second
Standard Deviation 0.75
|
1.72 tap amplitude per second
Standard Deviation 0.74
|
|
Motor Assessment 2: Finger Tapping (Speed)
Post-LIFUP Speed
|
1.70 tap amplitude per second
Standard Deviation 0.75
|
1.94 tap amplitude per second
Standard Deviation 0.80
|
PRIMARY outcome
Timeframe: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15The 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.
Outcome measures
| Measure |
Active LIFUP Session
n=29 Participants
LIFUP will be administered to the internal globus pallidus on the side of the brain contralateral to the side of the body with worse symptoms. The side of the brain contralateral to worse symptoms is being targeted because the left hemisphere of the brain primarily controls right side motor function and vice versa.
The LIFUP protocol will entail 20 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
Sham LIFUP Session
n=29 Participants
LIFUP will be administered with an identical protocol to the active session; however, the gel pad used during the sham session blocks the ultrasound such that none actually reaches the head.
|
|---|---|---|
|
Motor Assessment 2: 9-Hole Pegboard Dexterity Test
Post-LIFUP (Hand on side with less severe symptoms)
|
20.46 Seconds
Standard Deviation 5.79
|
20.12 Seconds
Standard Deviation 4.40
|
|
Motor Assessment 2: 9-Hole Pegboard Dexterity Test
Pre-LIFUP (Hand on side with more severe symptoms)
|
23.87 Seconds
Standard Deviation 9.44
|
23.94 Seconds
Standard Deviation 9.61
|
|
Motor Assessment 2: 9-Hole Pegboard Dexterity Test
Post-LIFUP (Hand on side with more severe symptoms)
|
23.49 Seconds
Standard Deviation 7.54
|
23.12 Seconds
Standard Deviation 7.34
|
|
Motor Assessment 2: 9-Hole Pegboard Dexterity Test
Pre-LIFUP (Hand on side with less severe symptoms)
|
21.04 Seconds
Standard Deviation 6.26
|
20.73 Seconds
Standard Deviation 7.50
|
SECONDARY outcome
Timeframe: During LIFUP (or sham) sonication on Day 1 and Day 15Population: Three participants were excluded from this analysis due to excessive motion or preprocessing failure.
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.
Outcome measures
| Measure |
Active LIFUP Session
n=27 Participants
LIFUP will be administered to the internal globus pallidus on the side of the brain contralateral to the side of the body with worse symptoms. The side of the brain contralateral to worse symptoms is being targeted because the left hemisphere of the brain primarily controls right side motor function and vice versa.
The LIFUP protocol will entail 20 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
Sham LIFUP Session
n=27 Participants
LIFUP will be administered with an identical protocol to the active session; however, the gel pad used during the sham session blocks the ultrasound such that none actually reaches the head.
|
|---|---|---|
|
Difference in BOLD fMRI Signal Between on vs. Off Blocks
|
1.19 BOLD signal change
Standard Deviation 6.53
|
0.41 BOLD signal change
Standard Deviation 3.49
|
SECONDARY outcome
Timeframe: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15Population: Data from the active session from 11 participants and from the sham session for 5 participants were excluded due to incomplete data or image reconstruction or preprocessing failures.
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.
Outcome measures
| Measure |
Active LIFUP Session
n=19 Participants
LIFUP will be administered to the internal globus pallidus on the side of the brain contralateral to the side of the body with worse symptoms. The side of the brain contralateral to worse symptoms is being targeted because the left hemisphere of the brain primarily controls right side motor function and vice versa.
The LIFUP protocol will entail 20 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
Sham LIFUP Session
n=25 Participants
LIFUP will be administered with an identical protocol to the active session; however, the gel pad used during the sham session blocks the ultrasound such that none actually reaches the head.
|
|---|---|---|
|
Perfusion Changes in Internal Globus Pallidus, External Globus Pallidus, and Putamen
GPi - Percent Change Perfusion
|
16.4 percentage change
Standard Deviation 50.6
|
17.0 percentage change
Standard Deviation 50.1
|
|
Perfusion Changes in Internal Globus Pallidus, External Globus Pallidus, and Putamen
GPe - Percent Change Perfusion
|
30.0 percentage change
Standard Deviation 101.2
|
16.6 percentage change
Standard Deviation 46.1
|
|
Perfusion Changes in Internal Globus Pallidus, External Globus Pallidus, and Putamen
Putamen - Percent Change Perfusion
|
28.4 percentage change
Standard Deviation 63.4
|
14.0 percentage change
Standard Deviation 45.7
|
Adverse Events
Active LIFUP Session
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sham LIFUP Session
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active LIFUP Session
n=30 participants at risk
LIFUP will be administered to the internal globus pallidus on the side of the brain contralateral to the side of the body with worse symptoms. The side of the brain contralateral to worse symptoms is being targeted because the left hemisphere of the brain primarily controls right side motor function and vice versa.
The LIFUP protocol will entail 20 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
Sham LIFUP Session
n=31 participants at risk
LIFUP will be administered with an identical protocol to the active session; however, the gel pad used during the sham session blocks the ultrasound such that none actually reaches the head.
|
|---|---|---|
|
Nervous system disorders
Head or Neck Pain
|
6.7%
2/30 • 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.
Participants were asked a series of open-ended questions 2, 4, and 7 days after each in-person sessions, as well as at the start of their second in person session (i.e. 2 weeks after session 1) . These questions asked participants if they had observed any 1. changes in impulsivity, anxiety, mood, or thinking skills, 2. motor changes, and 3. other changes, as well as if they had any other comments.
|
9.7%
3/31 • 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.
Participants were asked a series of open-ended questions 2, 4, and 7 days after each in-person sessions, as well as at the start of their second in person session (i.e. 2 weeks after session 1) . These questions asked participants if they had observed any 1. changes in impulsivity, anxiety, mood, or thinking skills, 2. motor changes, and 3. other changes, as well as if they had any other comments.
|
|
General disorders
Fatigue or Sleep Disruption
|
10.0%
3/30 • 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.
Participants were asked a series of open-ended questions 2, 4, and 7 days after each in-person sessions, as well as at the start of their second in person session (i.e. 2 weeks after session 1) . These questions asked participants if they had observed any 1. changes in impulsivity, anxiety, mood, or thinking skills, 2. motor changes, and 3. other changes, as well as if they had any other comments.
|
9.7%
3/31 • 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.
Participants were asked a series of open-ended questions 2, 4, and 7 days after each in-person sessions, as well as at the start of their second in person session (i.e. 2 weeks after session 1) . These questions asked participants if they had observed any 1. changes in impulsivity, anxiety, mood, or thinking skills, 2. motor changes, and 3. other changes, as well as if they had any other comments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place