Trial Outcomes & Findings for Low Intensity Focused Ultrasound Pulses (LIFUP) to Modulate Pain (NCT NCT04339972)
NCT ID: NCT04339972
Last Updated: 2021-08-19
Results Overview
Quantitative Sensory Testing (QST) is a valuable method for diagnosing peripheral nervous system disorders, including pain. This outcome quantifies the level of thermal stimulus temperature (degrees celsius) required for a participant to feel pain on their wrist. The temperatures will be recorded before and after LIFUP.
COMPLETED
NA
29 participants
Change from Baseline 45 minutes after LIFUP in the scanner
2021-08-19
Participant Flow
Participant milestones
| Measure |
Active LIFUP Followed by Sham LIFUP
Real LIFUP is delivered to the participant during this condition.
LIFUP: Low Intensity Focused Ultrasound Pulsation (LIFUP) is an interesting new form of brain stimulation that may be possible to stimulate non-invasively, safely, deep in the brain with focal precision.
|
Sham LIFUP Followed by Active LIFUP
Sham LIFUP (device turned on but no sonication delivered) during this condition
Sham LIFUP: The same as LIFUP but the device is not turned on and the subject does not receive any ultrasound.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Active LIFUP Followed by Sham LIFUP
Real LIFUP is delivered to the participant during this condition.
LIFUP: Low Intensity Focused Ultrasound Pulsation (LIFUP) is an interesting new form of brain stimulation that may be possible to stimulate non-invasively, safely, deep in the brain with focal precision.
|
Sham LIFUP Followed by Active LIFUP
Sham LIFUP (device turned on but no sonication delivered) during this condition
Sham LIFUP: The same as LIFUP but the device is not turned on and the subject does not receive any ultrasound.
|
|---|---|---|
|
Overall Study
Scheduling Issues
|
3
|
3
|
|
Overall Study
dropout
|
1
|
1
|
|
Overall Study
Technical issues
|
1
|
0
|
|
Overall Study
Claustraphobia
|
0
|
1
|
Baseline Characteristics
Low Intensity Focused Ultrasound Pulses (LIFUP) to Modulate Pain
Baseline characteristics by cohort
| Measure |
Active LIFUP Followed by Sham LIFUP
n=10 Participants
Real LIFUP is delivered to the participant during this condition.
LIFUP: Low Intensity Focused Ultrasound Pulsation (LIFUP) is an interesting new form of brain stimulation that may be possible to stimulate non-invasively, safely, deep in the brain with focal precision.
|
Sham LIFUP Followed by Active LIFUP
n=9 Participants
Sham LIFUP (device turned on but no sonication delivered) during this condition
Sham LIFUP: The same as LIFUP but the device is not turned on and the subject does not receive any ultrasound.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
24.5 years
STANDARD_DEVIATION 4.6 • n=99 Participants
|
24.5 years
STANDARD_DEVIATION 4.6 • n=107 Participants
|
24.5 years
STANDARD_DEVIATION 4.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline 45 minutes after LIFUP in the scannerPopulation: This was a crossover design so everyone in the study recieved both active and sham lifup, randomized order. Overall analysis was conducted in a repeated measure, within subject design for all 19 participants.
Quantitative Sensory Testing (QST) is a valuable method for diagnosing peripheral nervous system disorders, including pain. This outcome quantifies the level of thermal stimulus temperature (degrees celsius) required for a participant to feel pain on their wrist. The temperatures will be recorded before and after LIFUP.
Outcome measures
| Measure |
Active LIFUP
n=19 Participants
Real LIFUP is delivered to the participant for either visit 1 or visit 2.
|
Sham LIFUP
n=19 Participants
Sham LIFUP is delivered to the participant for visit 1 or visit 2.
|
|---|---|---|
|
Quantitative Sensory Threshold Temperature Levels (Degrees Celsius)
|
.51 Degrees Celsius
Standard Error .3
|
1.08 Degrees Celsius
Standard Error .28
|
PRIMARY outcome
Timeframe: Changes within 3 seconds after receiving LIFUPBlood oxygenation level dependent (BOLD) imaging is the standard technique used to generate images in functional MRI (fMRI) studies, and relies on regional differences in cerebral blood flow to delineate regional activity. We will measure the brain's BOLD signal as a response to thermal stimulus within the MRI scanner and determine whether a significant (p ≤ 0.005 uncorrected) increase or decrease in BOLD signal intensity is indicated as a result of either Active or Sham LIFUP.
Outcome measures
| Measure |
Active LIFUP
n=19 Participants
Real LIFUP is delivered to the participant for either visit 1 or visit 2.
|
Sham LIFUP
n=19 Participants
Sham LIFUP is delivered to the participant for visit 1 or visit 2.
|
|---|---|---|
|
Number of Participants With Significant Functional MRI Blood Oxygen Level Dependent (BOLD) Signal Changes
|
0 Participants w/ significant BOLD changes
|
0 Participants w/ significant BOLD changes
|
Adverse Events
Active LIFUP
Sham LIFUP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mark George or Dr. Bashar Badran
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place