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Low Intensity Focused Ultrasound for Emotion Regulation (LIFUPEMOT)

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ClinicalTrials.gov Identifier: NCT03782194
Recruitment Status : Not yet recruiting
First Posted : December 20, 2018
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Taylor Kuhn, University of California, Los Angeles

Brief Summary:
Amygdala is highly involved in emotional response, emotional reactivity and anxiety. Amygdala functions are therefore involved in a wide range of psychiatric disorders including generalized and social anxiety, specific phobia, obsessive compulsive disorder and posttraumatic stress disorder. Therefore, potential clinical implications of amygdala stimulation are great. However, to date, such efforts have been limited by the inability of non-invasive neuromodulation techniques (e.g. transcranial magnetic stimulation - TMS) to reach the amygdala and the highly invasive (i.e. neurosurgical) nature of methods (e.g. deep brain stimulation - DBS) which can, but to our knowledge has rarely been used, target these areas. In order to overcome these current limitations, study invesitgators propose the use of low intensity focused ultrasound pulsation (LIFUP) to affect amygdala activity to improve emotion regulation.

Condition or disease Intervention/treatment Phase
Psychiatric Disorder Anxiety Disorders PTSD Mood Disorders Social Anxiety Cognitive Impairment Device: Low Intensity Focused Ultrasound Pulsation Device: Sham Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participants will be blinded to whether or not the LIFUP transducer is on and, when on, what parameters are used. The investigator collecting the neuropsychological data will be blinded to which condition (LIFUP, sham) the participant completed during the session. The statistical analysts for both the neuropsychological and neuroimaging data will also be blinded to condition.
Primary Purpose: Other
Official Title: Low Intensity Focused Ultrasound as a Non-Invasive Neural Prosthetic for the Improvement of Emotion Regulation
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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.
Device: Low Intensity Focused Ultrasound Pulsation
A low intensity, focused ultrasound pulsation causes mechanical changed without causing heating or cavitation.

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.
Device: Sham Ultrasound
Low Intensity Focused Ultrasound Pulsation Transducer is left in place on the participant's head but is not turned on during the sham procedure.




Primary Outcome Measures :
  1. Emotion Reactivity [ Time Frame: Day 1 ]
    Psychophysiological reactivity, measured via Galvonic skin response, to emotionally salient images.


Secondary Outcome Measures :
  1. BOLD fMRI Signal in the Amygdala [ Time Frame: Day 1 ]
    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.

  2. Perfusion Arterial Spin Labeling (ASL) fMRI Signal throughout Brain [ Time Frame: Day 1 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782194


Contacts
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Contact: Taylor Kuhn, PhD 310-825-2283 tkuhn@mednet.ucla.edu
Contact: Malina Beatrice mbeatrice@mednet.ucla.edu

Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: Taylor Kuhn, Adjunct Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03782194    
Other Study ID Numbers: IRB#18-000978
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Taylor Kuhn, University of California, Los Angeles:
Ultrasound
MRI
Emotion
Reactivity
Reappraisal
Cognitive Neural Prosthetic
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Mood Disorders
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms