Trial Outcomes & Findings for Low Intensity Focused Ultrasound for Learning and Memory and Emotion Regulation (NCT NCT03717922)
NCT ID: NCT03717922
Last Updated: 2024-03-20
Results Overview
The Rey Auditory Verbal Learning Task is an assessment of verbal memory in which a list of 15 words is presented 5 times and participants are asked to repeat all the words they can remember immediately after each list presentation. This is followed by presentation and recall of an interference list. Immediately after the interference trial, the participant is asked to recall the original list. Then, 20 minutes later, they are asked to recall the original list again (delayed recall). "Learning Trials Total": Total number of words learned / successfully recalled across the five learning trials plus the post-interference immediate recall trial. This score does not include the words recalled from the interference list. "Delayed Recall": Total number of words recalled during the delayed recall trial of the Rey Auditory Verbal Learning Task
COMPLETED
NA
21 participants
Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
2024-03-20
Participant Flow
Participant milestones
| Measure |
Amygdala First, Then Entorhinal Cortex
Low Intensity focused ultrasound pulsation (LIFUP) will be administered to the amygdala while participants are in the MRI scanner. Then, 2 weeks later, entorhinal cortex LIFUP will be administered.
|
Entorhinal Cortex First, Then Amygdala
Low Intensity focused ultrasound pulsation (LIFUP) will be administered to the entorhinal cortex while participants are in the MRI scanner. Then, 2 weeks later, amygdala LIFUP will be administered.
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|---|---|---|
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Overall Study
STARTED
|
10
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11
|
|
Overall Study
Completed Visit 1
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10
|
11
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Amygdala First, Then Entorhinal Cortex
Low Intensity focused ultrasound pulsation (LIFUP) will be administered to the amygdala while participants are in the MRI scanner. Then, 2 weeks later, entorhinal cortex LIFUP will be administered.
|
Entorhinal Cortex First, Then Amygdala
Low Intensity focused ultrasound pulsation (LIFUP) will be administered to the entorhinal cortex while participants are in the MRI scanner. Then, 2 weeks later, amygdala LIFUP will be administered.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Low Intensity Focused Ultrasound for Learning and Memory and Emotion Regulation
Baseline characteristics by cohort
| Measure |
Amygdala First, Then Entorhinal Cortex
n=10 Participants
Low Intensity focused ultrasound pulsation (LIFUP) will be administered to the amygdala while participants are in the MRI scanner. Then, 2 weeks later, entorhinal cortex LIFUP will be administered.
|
Entorhinal Cortex First, Then Amygdala
n=11 Participants
Low Intensity focused ultrasound pulsation (LIFUP) will be administered to the entorhinal cortex while participants are in the MRI scanner. Then, 2 weeks later, amygdala LIFUP will be administered.
|
Total
n=21 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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60.1 years
STANDARD_DEVIATION 8.2 • n=93 Participants
|
61.2 years
STANDARD_DEVIATION 9.5 • n=4 Participants
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60.7 years
STANDARD_DEVIATION 8.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
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4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
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Region of Enrollment
United States
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10 participants
n=93 Participants
|
11 participants
n=4 Participants
|
21 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15Population: All participants who completed this assessment before and after LIFUP at both the entorhinal cortex and the amygdala visits were included in analyses
The Rey Auditory Verbal Learning Task is an assessment of verbal memory in which a list of 15 words is presented 5 times and participants are asked to repeat all the words they can remember immediately after each list presentation. This is followed by presentation and recall of an interference list. Immediately after the interference trial, the participant is asked to recall the original list. Then, 20 minutes later, they are asked to recall the original list again (delayed recall). "Learning Trials Total": Total number of words learned / successfully recalled across the five learning trials plus the post-interference immediate recall trial. This score does not include the words recalled from the interference list. "Delayed Recall": Total number of words recalled during the delayed recall trial of the Rey Auditory Verbal Learning Task
Outcome measures
| Measure |
LIFUP to Entorhinal Cortex
n=17 Participants
LIFUP will be administered to the entorhinal cortex in 10 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
LIFUP to Amygdala
n=17 Participants
LIFUP will be administered to the amygdala in 10 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 10Hz, duration 30s, with 30s spacing between sonications.
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|---|---|---|
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Rey Auditory Verbal Learning Task
Pre-LIFUP Learning Trials Total
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50.00 Words Recalled
Standard Deviation 11.09
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50.29 Words Recalled
Standard Deviation 9.79
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Rey Auditory Verbal Learning Task
Post-LIFUP Learning Trials Total
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47.59 Words Recalled
Standard Deviation 9.21
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47.88 Words Recalled
Standard Deviation 11.10
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Rey Auditory Verbal Learning Task
Pre-LIFUP Delayed Recall
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10.18 Words Recalled
Standard Deviation 2.98
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10.06 Words Recalled
Standard Deviation 2.68
|
|
Rey Auditory Verbal Learning Task
Post-LIFUP Delayed Recall
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8.82 Words Recalled
Standard Deviation 3.43
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8.47 Words Recalled
Standard Deviation 3.66
|
PRIMARY outcome
Timeframe: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15Population: All participants who completed this assessment before and after LIFUP at both the entorhinal cortex and the amygdala visits were included in analyses. One additional participant was removed due to presumed accidental reversal of the scale during the pre-LIFUP assessment, in which all of their responses were exactly flipped relative to their post-LIFUP responses.
The "state" section of the State Trait Anxiety Inventory. This is a 20-question self-report assessment in which participants are asked about how they feel "right now, at this very moment" in order to assess current anxiety levels. Each item is scored on a scale of 1 to 4 points. The total assessment has a range of 20 to 80 points. Higher scores represent higher levels of anxiety.
Outcome measures
| Measure |
LIFUP to Entorhinal Cortex
n=16 Participants
LIFUP will be administered to the entorhinal cortex in 10 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
LIFUP to Amygdala
n=16 Participants
LIFUP will be administered to the amygdala in 10 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 10Hz, duration 30s, with 30s spacing between sonications.
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|---|---|---|
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State Trait Anxiety Inventory - State (STAIS)
STAIS Pre-LIFUP
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25.81 score on a scale
Standard Deviation 6.67
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30.69 score on a scale
Standard Deviation 12.00
|
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State Trait Anxiety Inventory - State (STAIS)
STAIS Post-LIFUP
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29.25 score on a scale
Standard Deviation 10.64
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30.63 score on a scale
Standard Deviation 15.09
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PRIMARY outcome
Timeframe: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15Population: All participants who completed both pre and post-LIFUP arterial spin labeling scans at both visits
Average perfusion in a given region of interest, as measured by arterial spin labeling. Percent change values calculated as ((Post LIFUP Perfusion - Pre LIFUP Perfusion)/Pre LIFUP Perfusion).
Outcome measures
| Measure |
LIFUP to Entorhinal Cortex
n=17 Participants
LIFUP will be administered to the entorhinal cortex in 10 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
LIFUP to Amygdala
n=17 Participants
LIFUP will be administered to the amygdala in 10 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 10Hz, duration 30s, with 30s spacing between sonications.
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|---|---|---|
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Average Perfusion in Regions Of Interest
Percent Change Perfusion in the Left Entorhinal Cortex
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15.75 Percent
Standard Deviation 23
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6.72 Percent
Standard Deviation 34
|
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Average Perfusion in Regions Of Interest
Percent Change Perfusion in the Right Amygdala
|
7.07 Percent
Standard Deviation 35
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19.52 Percent
Standard Deviation 38
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SECONDARY outcome
Timeframe: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15Population: All participants who completed the IAPS ERT at all timepoints
An emotional reactivity and reappraisal task (ERT) using images from the International Picture Affective System (IAPS). Arousal ratings ranged from 1 (low arousal, "calm") to 9 (high arousal, "excited"). Valence ratings ranged from 1 (negative, "unhappy") to 9 (positive, "happy"). There were 3 instruction conditions: "WATCH", in which a participant was instructed to passively view a negatively-valenced image, "VIEW", in which they were instructed to passively view a neutral image, and "REAPPRAISE", in which participants were asked to change their emotional response to neutral in response to a negatively-valenced image by altering their cognitive construal of the image. The reported metric "reactivity" was taken from subtracting average responses to "VIEW" from average response to WATCH (i.e. WATCH - VIEW). Reappraisal metric is calculated as REAPPRAISE - WATCH
Outcome measures
| Measure |
LIFUP to Entorhinal Cortex
n=15 Participants
LIFUP will be administered to the entorhinal cortex in 10 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
LIFUP to Amygdala
n=15 Participants
LIFUP will be administered to the amygdala in 10 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 10Hz, duration 30s, with 30s spacing between sonications.
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|---|---|---|
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Emotional Reactivity Task
Pre-LIFUP Reactivity - Arousal
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2.24 score on a scale
Standard Deviation 2.78
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2.20 score on a scale
Standard Deviation 2.62
|
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Emotional Reactivity Task
Post-LIFUP Reactivity - Arousal
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2.14 score on a scale
Standard Deviation 2.98
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3.02 score on a scale
Standard Deviation 2.25
|
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Emotional Reactivity Task
Pre-LIFUP Reappraisal - Arousal
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-0.10 score on a scale
Standard Deviation 0.55
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-0.18 score on a scale
Standard Deviation 0.45
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Emotional Reactivity Task
Post-LIFUP Reappraisal - Arousal
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0.22 score on a scale
Standard Deviation 0.97
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-0.36 score on a scale
Standard Deviation 0.94
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Emotional Reactivity Task
Pre-LIFUP Reactivity - Valence
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-3.06 score on a scale
Standard Deviation 1.84
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-3.44 score on a scale
Standard Deviation 1.31
|
|
Emotional Reactivity Task
Post-LIFUP Reactivity - Valence
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-2.65 score on a scale
Standard Deviation 3.14
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-3.21 score on a scale
Standard Deviation 1.71
|
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Emotional Reactivity Task
Pre-LIFUP Reappraisal - Valence
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0.54 score on a scale
Standard Deviation 1.11
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0.37 score on a scale
Standard Deviation 0.87
|
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Emotional Reactivity Task
Post-LIFUP Reappraisal - Valence
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0.07 score on a scale
Standard Deviation 0.19
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0.32 score on a scale
Standard Deviation 0.83
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SECONDARY outcome
Timeframe: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15Population: All participants who completed the assessment at all time points
Performance on the delayed recall (DR) portion of the Brief Visuospatial Memory Test (BVMT). Score is on a scale of 0-12, with higher scores indicating a better outcome. A score of 12 points represents full recall of all figures in their correct locations.
Outcome measures
| Measure |
LIFUP to Entorhinal Cortex
n=16 Participants
LIFUP will be administered to the entorhinal cortex in 10 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 100Hz, duration 30s, with 30s spacing between sonications.
|
LIFUP to Amygdala
n=16 Participants
LIFUP will be administered to the amygdala in 10 sonications at 650kHz, 720mW/cm, duty cycle 5%, pulse repetition frequency 10Hz, duration 30s, with 30s spacing between sonications.
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|---|---|---|
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Brief Visuospatial Memory Test
BVMT DR Pre-LIFUP
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9.63 score on a scale
Standard Deviation 2.16
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10.50 score on a scale
Standard Deviation 1.41
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Brief Visuospatial Memory Test
BVMT DR Post-LIFUP
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8.56 score on a scale
Standard Deviation 3.03
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8.63 score on a scale
Standard Deviation 2.83
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Adverse Events
Low Intensity Focused Ultrasound Pulsation to Amygdala
Low Intensity Focused Ultrasound Pulsation to Entorhinal Cortex
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Intensity Focused Ultrasound Pulsation to Amygdala
n=21 participants at risk
Low intensity focused ultrasound pulsation will be administered to the amygdala in 10 sonications at 650kHz, ispta 720mW/cm, pulse repetition frequency 10Hz, duty cycle 5% duration 30s, with 30s spacing between sonications. Prior to receiving LIFUP sonication, the LIFUP transducer will be aimed at the amygdala and gently strapped in place to their head. Participants will then return to the scanner where a T1 image will verify the position of the LIFUP transducer and allow for estimation of the spatial location of the sonication beam focus. If needed, adjustments to transducer placement will be made to ensure that the beam focus is correctly aimed; an additional T1 will be collected after adjustment. Once correct placement of the transducer has been confirmed, LIFUP will be administered.
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Low Intensity Focused Ultrasound Pulsation to Entorhinal Cortex
n=21 participants at risk
Low intensity focused ultrasound pulsation will be administered to the entorhinal cortex in 10 sonications at 650kHz, ispta 720mW/cm, pulse repetition frequency 100Hz, duty cycle 5% duration 30s, with 30s spacing between sonications. Prior to receiving LIFUP sonication, the LIFUP transducer will be aimed at the entorhinal cortex and gently strapped in place to their head. Participants will then return to the scanner where a T1 image will verify the position of the LIFUP transducer and allow for estimation of the spatial location of the sonication beam focus. If needed, adjustments to transducer placement will be made to ensure that the beam focus is correctly aimed; an additional T1 will be collected after adjustment. Once correct placement of the transducer has been confirmed, LIFUP will be administered.
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|---|---|---|
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Psychiatric disorders
Emotional distress following sonication
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4.8%
1/21 • Number of events 1 • Data was collected on Day 1 and Day 15
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0.00%
0/21 • Data was collected on Day 1 and Day 15
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Additional Information
Dr. Taylor P. Kuhn, PhD
UCLA Psychiatry & Biobehavioral Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place