Low Intensity Focused Ultrasound for Learning and Memory and Emotion Regulation

Summary

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.

Conditions

• Brain Diseases
• Memory Disorders
• Learning Disabilities
• Cognitive Impairment

Interventions

DEVICE

Low Intensity Focused Ultrasound Pulsation to Amygdala

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.

DEVICE

Low Intensity Focused Ultrasound Pulsation to Entorhinal Cortex

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.

Sponsors & Collaborators

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Taylor P Kuhn, PhD · UCLA Longevity Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

35 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-28

Primary Completion

2022-12-20

Completion

2022-12-20

FDA Device

Yes

Countries

• United States

Study Locations