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NCT03717922: LIFUPMEMEMOT

Low Intensity Focused Ultrasound for Learning and Memory and Emotion Regulation

Completed NA Results posted Last updated 20 March 2024
What this trial tests

NA trial testing Low Intensity Focused Ultrasound Pulsation to Amygdala in Brain Diseases in 21 participants. Completed in 20 December 2022.

Timeline
28 June 2019
Primary endpoint
20 December 2022
20 December 2022

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposeother
Enrollment21
Start date28 June 2019
Primary completion20 December 2022
Estimated completion20 December 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

Adults 35 to 90, any sex, with Brain Diseases or Memory Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rey Auditory Verbal Learning Task Primary · Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

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

Pre-LIFUP Learning Trials Total
GroupValue95% CI
LIFUP to Entorhinal Cortex50.00± 11.09
LIFUP to Amygdala50.29± 9.79
Post-LIFUP Learning Trials Total
GroupValue95% CI
LIFUP to Entorhinal Cortex47.59± 9.21
LIFUP to Amygdala47.88± 11.10
Pre-LIFUP Delayed Recall
GroupValue95% CI
LIFUP to Entorhinal Cortex10.18± 2.98
LIFUP to Amygdala10.06± 2.68
Post-LIFUP Delayed Recall
GroupValue95% CI
LIFUP to Entorhinal Cortex8.82± 3.43
LIFUP to Amygdala8.47± 3.66
State Trait Anxiety Inventory - State (STAIS) Primary · Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

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.

STAIS Pre-LIFUP
GroupValue95% CI
LIFUP to Entorhinal Cortex25.81± 6.67
LIFUP to Amygdala30.69± 12.00
STAIS Post-LIFUP
GroupValue95% CI
LIFUP to Entorhinal Cortex29.25± 10.64
LIFUP to Amygdala30.63± 15.09
Average Perfusion in Regions Of Interest Primary · Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

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).

Percent Change Perfusion in the Left Entorhinal Cortex
GroupValue95% CI
LIFUP to Entorhinal Cortex15.75± 23
LIFUP to Amygdala6.72± 34
Percent Change Perfusion in the Right Amygdala
GroupValue95% CI
LIFUP to Entorhinal Cortex7.07± 35
LIFUP to Amygdala19.52± 38
Emotional Reactivity Task Secondary · Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

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

Pre-LIFUP Reactivity - Arousal
GroupValue95% CI
LIFUP to Entorhinal Cortex2.24± 2.78
LIFUP to Amygdala2.20± 2.62
Post-LIFUP Reactivity - Arousal
GroupValue95% CI
LIFUP to Entorhinal Cortex2.14± 2.98
LIFUP to Amygdala3.02± 2.25
Pre-LIFUP Reappraisal - Arousal
GroupValue95% CI
LIFUP to Entorhinal Cortex-0.10± 0.55
LIFUP to Amygdala-0.18± 0.45
Post-LIFUP Reappraisal - Arousal
GroupValue95% CI
LIFUP to Entorhinal Cortex0.22± 0.97
LIFUP to Amygdala-0.36± 0.94
Pre-LIFUP Reactivity - Valence
GroupValue95% CI
LIFUP to Entorhinal Cortex-3.06± 1.84
LIFUP to Amygdala-3.44± 1.31
Post-LIFUP Reactivity - Valence
GroupValue95% CI
LIFUP to Entorhinal Cortex-2.65± 3.14
LIFUP to Amygdala-3.21± 1.71
Pre-LIFUP Reappraisal - Valence
GroupValue95% CI
LIFUP to Entorhinal Cortex0.54± 1.11
LIFUP to Amygdala0.37± 0.87
Post-LIFUP Reappraisal - Valence
GroupValue95% CI
LIFUP to Entorhinal Cortex0.07± 0.19
LIFUP to Amygdala0.32± 0.83
Brief Visuospatial Memory Test Secondary · Pre-LIFUP and Post-LIFUP at Day 1 and Day 15

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.

BVMT DR Pre-LIFUP
GroupValue95% CI
LIFUP to Entorhinal Cortex9.63± 2.16
LIFUP to Amygdala10.50± 1.41
BVMT DR Post-LIFUP
GroupValue95% CI
LIFUP to Entorhinal Cortex8.56± 3.03
LIFUP to Amygdala8.63± 2.83

Adverse events — posted to ClinicalTrials.gov

Time frame: Data was collected on Day 1 and Day 15. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Low Intensity Focused Ultrasound Pulsation to Amygdala
Serious: 0/21 (0%)
Deaths: 0/21
Low Intensity Focused Ultrasound Pulsation to Entorhinal Cortex
Serious: 0/21 (0%)
Deaths: 0/21
Other adverse events (1 terms — click to expand)

ReactionSystemLow Intensity Focused Ultr…Low Intensity Focused Ultr…
Emotional distress following sonicationPsychiatric disorders

Data from ClinicalTrials.gov NCT03717922 adverse events section.

Sponsor's own description

The goal of this clinical trial is to investigate the impact of low intensity focused ultrasound pulsation (LIFUP) to two different brain regions, the amygdala and entorhinal cortex, in older adults. The main questions it aims to answer are: 1. Will LIFUP change brain activity in the targeted regions? 2. Will LIFUP to the amygdala have an impact on anxiety and emotion regulation? 3. Will LIFUP to the entorhinal cortex have an impact on memory performance? Participants will complete two in-person visits including neuropsychological testing, MRI of the brain, and LIFUP to the brain.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Ultrasound Therapy: Experiences and Perspectives for Regenerative Medicine.
    de Lucas B, Pérez LM, Bernal A, Gálvez BG. · · 2020 · cited 38× · PMID 32957737 · DOI 10.3390/genes11091086
  2. Low-intensity focused ultrasound for the treatment of brain diseases: safety and feasibility.
    Toccaceli G, Barbagallo G, Peschillo S. · · 2019 · cited 26× · PMID 30809291 · DOI 10.7150/thno.31765
  3. Transcranial Focused Ultrasound Targeting the Amygdala May Increase Psychophysiological and Subjective Negative Emotional Reactivity in Healthy Older Adults.
    Hoang-Dang B, Hoang-Dang B, Halavi SE, Rotstein NM, et al · · 2024 · cited 16× · PMID 39092138 · DOI 10.1016/j.bpsgos.2024.100342
  4. Targeted manipulation of pain neural networks: The potential of focused ultrasound for treatment of chronic pain.
    Todd N, McDannold N, Borsook D. · · 2020 · cited 13× · PMID 32534900 · DOI 10.1016/j.neubiorev.2020.06.007
  5. Alterations in large-scale resting-state network nodes following transcranial focused ultrasound of deep brain structures.
    Gorka SM, Jimmy J, Koning K, Phan KL, et al · · 2024 · cited 4× · PMID 39698148 · DOI 10.3389/fnhum.2024.1486770

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Other recruiting trials for Brain Diseases

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03717922.

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