Low Intensity Focused Ultrasound for Emotion Regulation (LIFUPEMOT)
Low Intensity Focused Ultrasound as a Non-Invasive Neural Prosthetic for the Improvement of Emotion Regulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study investigators propose the use of personalized neuronavigation, based on each participant's structural brain MRI, to aim LIFUP at the amygdala in the pursuit of enhancement of emotionality in humans. A comprehensive approach will integrate behavioral and multimodal neuroimaging to assess the utility of LIFUP to increase activity in deep neural structures and in the regulation of anxiety. Further, this is the first study to use LIFUP in (A) amygdala in humans and (B) for pro-cognitive effects. Findings from this study will provide important insight into the utility of LIFUP modulation of subcortical regions and their associated networks and functions, which have wide ranging implications for clinical LIFUP as a therapeutic device for numerous patient populations. By characterizing the effect of LIFUP on the amygdala and associated networks, this study will provide the foundation on which LIFUP can be validated as an effective neural prosthetic and as a treatment tools for psychiatric patient populations.
Participants will complete a brief T1-weighted structural brain scan. Then, they will be removed from the scanner and, using the T1 image in Neurocare Brainsight software, 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 second T1 image will verify the position of the LIFUP transducer and allow for estimation of the spatial location of the sonification beam focus (approximately .5cm long x 7mm diameter). Blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) will be collected during two conditions: short train sonification LIFUP and sham LIFUP: total time = 20min. Short train LIFUP (previously used in primary sensory cortices47 will be administered in 75 sonifications at 210 Kilohertz (KHz) frequency with pulse repetition frequency of 500 Hertz (Hz), 35mW/cm2, sonification duration 0.5s with 7s inter-stimulation interval. Sham LIFUP will involve the same procedures (e.g. participant provided the same instructions) except the sonification will not occur. Before and after completing the scan and a short break, these participants will receive short train LIFUP while they are administered a series of three computerized, amygdala-mediated emotion reactivity and regulation tasks. Given that routine clinical neuropsychological measures are designed to provide diagnostic information and are not sensitive or specific enough to precisely measure longitudinal emotional change related to an intervention, investigators will use validated experimental neurocognitive measures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095
- University of California, Los Angeles
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must be between 18-65 years of age
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: MRI ultrasound sonication
Low Intensity focused ultrasound pulsation will be administered to participants while they are in the fMRI scanner.
Functional and perfusion MRI data will be collected before and after the sonication to allow for comparisons and investigation of pre and post sonication functional activation and connectivity.
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A low intensity, focused ultrasound pulsation causes mechanical changed without causing heating or cavitation.
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Sham Comparator: Sham Ultrasound
While in the fMRI scanner, participants will have the ultrasound transducer attached to their head in the same manner as during the actual ultrasound sonication.
However, during this portion of the experiment, the transducer will not be turned on.
Previous, published experiments indicate that participants are unable to differentiate between when the transducer is on and off.
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Low Intensity Focused Ultrasound Pulsation Transducer is left in place on the participant's head but is not turned on during the sham procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion Reactivity
Time Frame: Day 1
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Psychophysiological reactivity, measured via Galvonic skin response, to emotionally salient images.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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BOLD fMRI Signal in the Amygdala
Time Frame: Day 1
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BOLD data will be collected in real-time during the ultrasound sonication, which occurs in on-off blocks.
Analyses will assess the statistical relationship between BOLD signal in the brain and the time series (on vs off) of the ultrasound sonication.
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Day 1
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Perfusion Arterial Spin Labeling (ASL) fMRI Signal throughout Brain
Time Frame: Day 1
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Perfusion ASL fMRI data will be collected before and after sonication.
Analyses will assess the statistical relationship between ASL signal throughout the brain pre and post sonication in a within subject repeated measures design.
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Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#18-000978
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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