Trial Outcomes & Findings for Investigation of Low-intensity Focused Ultrasound Parameters (NCT NCT05134233)
NCT ID: NCT05134233
Last Updated: 2025-01-23
Results Overview
Changes in waveform peak will be observed per each variable application of LIFU
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Outcome measured throughout study participation - an average of 4 weeks per participant.
Results posted on
2025-01-23
Participant Flow
Participant milestones
| Measure |
Parameter Trials
Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG.
Low-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.
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|---|---|
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Overall Study
STARTED
|
23
|
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Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Parameter Trials
Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG.
Low-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.
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|---|---|
|
Overall Study
Pregnancy
|
1
|
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Overall Study
MEP value too low
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Investigation of Low-intensity Focused Ultrasound Parameters
Baseline characteristics by cohort
| Measure |
Parameter Trials
n=23 Participants
Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG.
Low-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Age, Continuous
|
29 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome measured throughout study participation - an average of 4 weeks per participant.Population: One participant data set had artifacts that could not be removed while leaving usable MEP data.
Changes in waveform peak will be observed per each variable application of LIFU
Outcome measures
| Measure |
Parameter Trials
n=18 Participants
Up to 15 parameter combinations will be tested per study session, expected up to 6 sessions of trials. Response recorded using TMS and EMG.
Low-intensity Focused Ultrasound: LIFU application using various parameters, responses of neuromodulation recorded using TMS and EMG.
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|---|---|
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Waveforms
Parameter 19 (24W/cm2-50%DC-500msec)
|
0.93 percentage of baseline MEP mV
Standard Deviation 0.13
|
|
Waveforms
Parameter 1 (6W/cm2-1%DC-100msec)
|
1.06 percentage of baseline MEP mV
Standard Deviation 0.12
|
|
Waveforms
Parameter 2 (6W/cm2-10%DC-100msec)
|
1.10 percentage of baseline MEP mV
Standard Deviation 0.12
|
|
Waveforms
Parameter 3 (6W/cm2-30%DC-100msec)
|
0.97 percentage of baseline MEP mV
Standard Deviation .10
|
|
Waveforms
Parameter 4 (6W/cm2-50%DC-100msec)
|
0.99 percentage of baseline MEP mV
Standard Deviation 0.10
|
|
Waveforms
Parameter 5 (6W/cm2-70%DC-100msec)
|
1.03 percentage of baseline MEP mV
Standard Deviation 0.13
|
|
Waveforms
Parameter 6 (6W/cm2-1%DC-500msec)
|
0.80 percentage of baseline MEP mV
Standard Deviation 0.10
|
|
Waveforms
Parameter 7 (6W/cm2-10%DC-500msec)
|
0.84 percentage of baseline MEP mV
Standard Deviation 0.10
|
|
Waveforms
Parameter 8 (6W/cm2-30%DC-500msec)
|
0.70 percentage of baseline MEP mV
Standard Deviation 0.08
|
|
Waveforms
Parameter 9 (6W/cm2-50%DC-500msec)
|
0.81 percentage of baseline MEP mV
Standard Deviation 0.11
|
|
Waveforms
Parameter 10 (6W/cm2-70%DC-500msec)
|
0.75 percentage of baseline MEP mV
Standard Deviation 0.08
|
|
Waveforms
Parameter 11 (24W/cm2-1%DC-100msec)
|
0.86 percentage of baseline MEP mV
Standard Deviation 0.09
|
|
Waveforms
Parameter 12 (24W/cm2-10%DC-100msec)
|
0.93 percentage of baseline MEP mV
Standard Deviation 0.11
|
|
Waveforms
Parameter 13 (24W/cm2-30%DC-100msec)
|
1.01 percentage of baseline MEP mV
Standard Deviation 0.12
|
|
Waveforms
Parameter 14 (24W/cm2-50%DC-100msec)
|
0.91 percentage of baseline MEP mV
Standard Deviation 0.12
|
|
Waveforms
Parameter 15 (24W/cm2-70%DC-100msec)
|
0.91 percentage of baseline MEP mV
Standard Deviation 0.09
|
|
Waveforms
Parameter 16 (24W/cm2-1%DC-500msec)
|
0.75 percentage of baseline MEP mV
Standard Deviation 0.07
|
|
Waveforms
Parameter 17 (24W/cm2-10%DC-500msec)
|
0.79 percentage of baseline MEP mV
Standard Deviation 0.10
|
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Waveforms
Parameter 18 (24W/cm2-30%DC-500msec)
|
0.84 percentage of baseline MEP mV
Standard Deviation 0.10
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Waveforms
Parameter 20 (24W/cm2-70%DC-500msec)
|
0.84 percentage of baseline MEP mV
Standard Deviation 0.09
|
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Waveforms
Parameter 21 (continuous- 6W/cm2-35000 cycles)
|
0.84 percentage of baseline MEP mV
Standard Deviation .11
|
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Waveforms
Parameter 22 (continuous- 24W/cm2-35000 cycles)
|
1.05 percentage of baseline MEP mV
Standard Deviation 0.13
|
|
Waveforms
Parameter 23 (continuous- 6W/cm2-75000 cycles)
|
1.10 percentage of baseline MEP mV
Standard Deviation 0.13
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|
Waveforms
Parameter 24 (continuous- 24W/cm2-75000 cycles)
|
0.99 percentage of baseline MEP mV
Standard Deviation 0.10
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Adverse Events
Parameter Trials
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jessica Florig
Fralin Biomedical Research Institute at VTC
Phone: 540-526-2261
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place