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LIFU for Anxiety Management

Primary Purpose

Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low-intensity focused ultrasound
Low-intensity focused ultrasound - sham
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: High or low trait anxiety Exclusion Criteria: claustrophobia Contraindications to MRI (implants) Contraindications to CT (pregnancy) Active medical disorder with CNS effects (e.g. Alzheimers) History of neurologic disorder (e.g. Parkinson's, epilepsy) History of head injury w/ LOC for >10 min History of alcohol or drug dependence History of current cardiovascular disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    NPU

    NPU-c

    Arm Description

    Participant will be presented with a series of images (cues) and sounds. Three conditions will occur - a no shock (N), predictable shock (P), and unpredictable shock (U). In P, shocks will only occur with the cue. In U, shocks will happen at any time. Participants will be told which condition they are in throughout the task. Startle sounds will occur throughout. 3 Study visits will occur - identical conditions for the participant, testing 2 brain regions and 1 sham visit.

    Participants will be presented with a moving line. When the line reaches a certain point - an event will occur. This event will either be a painful shock or a monetary reward. Startle sounds will occur throughout. 3 study visits will occur - identical conditions for the participant, testing 2 brain regions and 1 sham visit.

    Outcomes

    Primary Outcome Measures

    Change in EMG eye startle reflex
    Attenuated amplitude of startle reflex during uncertain and predictable threat tasks with lifu compared to sham.
    Change in heart rate using ECG
    Attenuation of hear rate increases due to startle tasks in lifu compared to sham condition

    Secondary Outcome Measures

    Full Information

    First Posted
    March 28, 2023
    Last Updated
    August 29, 2023
    Sponsor
    Virginia Polytechnic Institute and State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05839847
    Brief Title
    LIFU for Anxiety Management
    Official Title
    Investigation of Low-intensity Focused Ultrasound for Human Anxiety Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 20, 2023 (Anticipated)
    Primary Completion Date
    April 1, 2025 (Anticipated)
    Study Completion Date
    April 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Virginia Polytechnic Institute and State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is examining the effects of noninvasive brain stimulation on anxiety. Low-intensity focused ultrasound (LIFU) will be utilized to neuromodulate the brain prior to a task (NPU). Physiological recordings will be taken throughout (EEG, EMG, HR, BP, RR, GSR).
    Detailed Description
    This study is a research project examining the effects of noninvasive brain stimulation on anxiety. This study will help us to better understand possible treatments for patients diagnosed with anxiety disorders. Participants will undergo a functional magnetic resonance imaging (fMRI) and a computed tomography (CT) scan, to image the bone and brain tissue. Participants will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Participants will undergo a threat task involving brief (100ms) shocks (1-5mA) and startle noises. Brain signals (EEG), muscle twitch (EMG), heart rate and rhythm, blood pressure, respiration rate, and skin moisture will be monitored throughout. Participants will be asked to complete behavioral questionnaires.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Participants will act as their own sham - sham vs real will be conducted in separate study visits. 2 arms exist for 2 variations of the NPU task.
    Masking
    Participant
    Masking Description
    Participant will experience the same setup in real and sham conditions. The gel puck used to couple the ultrasound signal will either have a blocking disk, or no blocking disk to either allow or block the ultrasound signal.
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NPU
    Arm Type
    Experimental
    Arm Description
    Participant will be presented with a series of images (cues) and sounds. Three conditions will occur - a no shock (N), predictable shock (P), and unpredictable shock (U). In P, shocks will only occur with the cue. In U, shocks will happen at any time. Participants will be told which condition they are in throughout the task. Startle sounds will occur throughout. 3 Study visits will occur - identical conditions for the participant, testing 2 brain regions and 1 sham visit.
    Arm Title
    NPU-c
    Arm Type
    Experimental
    Arm Description
    Participants will be presented with a moving line. When the line reaches a certain point - an event will occur. This event will either be a painful shock or a monetary reward. Startle sounds will occur throughout. 3 study visits will occur - identical conditions for the participant, testing 2 brain regions and 1 sham visit.
    Intervention Type
    Device
    Intervention Name(s)
    Low-intensity focused ultrasound
    Intervention Description
    A noninvasive brain stimulation device using low-intensity focused ultrasound (LIFU) - ultrasound will be used to test whether noninvasive brain stimulation can reduce reactions to sensory stimuli.
    Intervention Type
    Device
    Intervention Name(s)
    Low-intensity focused ultrasound - sham
    Intervention Description
    A sham condition that will mimic the application of LIFU without actually administering any ultrasound to the brain.
    Primary Outcome Measure Information:
    Title
    Change in EMG eye startle reflex
    Description
    Attenuated amplitude of startle reflex during uncertain and predictable threat tasks with lifu compared to sham.
    Time Frame
    Through study completion, an average of 2 weeks
    Title
    Change in heart rate using ECG
    Description
    Attenuation of hear rate increases due to startle tasks in lifu compared to sham condition
    Time Frame
    Through study completion, an average of 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: High or low trait anxiety Exclusion Criteria: claustrophobia Contraindications to MRI (implants) Contraindications to CT (pregnancy) Active medical disorder with CNS effects (e.g. Alzheimers) History of neurologic disorder (e.g. Parkinson's, epilepsy) History of head injury w/ LOC for >10 min History of alcohol or drug dependence History of current cardiovascular disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jessica Florig, MPH
    Phone
    540-526-2261
    Email
    jnw@vtc.vt.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    LIFU for Anxiety Management

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