Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anxiety Disorders
  • Cognitive Impairment
  • Mood Disorders
  • Psychiatric Disorder
  • PTSD
  • Social Anxiety
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: 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

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 ut...

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.

Tracking Information

NCT #
NCT03782194
Collaborators
Not Provided
Investigators
Not Provided