Cognitive Impairment Clinical Trial
— LIFUPMEMEMOTOfficial title:
Low Intensity Focused Ultrasound of Medial Temporal Lobe Regions for the Improvement of Learning and Memory / Low Intensity Focused Ultrasound as a Non-Invasive Neural Prosthetic for the Improvement of Emotion Regulation
Verified date | March 2024 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | December 20, 2022 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 35 Years to 90 Years |
Eligibility | Inclusion Criteria: - Must be right handed - English must be the dominant language Exclusion Criteria: - contraindications for MRI (e.g. metal implants, pregnancy) - history of head injury sufficient to warrant medical attention - history of alcohol abuse or dependence - history of substance abuse or dependence - history of major psychiatric illness requiring treatment - history of cancer or other neoplastic syndromes - history of major neurologic illness (e.g. epilepsy). |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rey Auditory Verbal Learning Task | 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 |
Pre-LIFUP and Post-LIFUP at Day 1 and Day 15 | |
Primary | State Trait Anxiety Inventory - State (STAIS) | 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. | Pre-LIFUP and Post-LIFUP at Day 1 and Day 15 | |
Primary | Average Perfusion in Regions Of Interest | 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). | Pre-LIFUP and Post-LIFUP at Day 1 and Day 15 | |
Secondary | Emotional Reactivity Task | 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 |
Pre-LIFUP and Post-LIFUP at Day 1 and Day 15 | |
Secondary | Brief Visuospatial Memory Test | 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. | Pre-LIFUP and Post-LIFUP at Day 1 and Day 15 |
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