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Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function

Primary Purpose

Depressive Disorder, Major

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LIFUP sonication to the amygdala
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depressive Disorder, Major focused on measuring depression, mental illness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be right-handed
  • Must be illicit drug-free at the time of scanning as appropriate (verified by negative urine drug screen)
  • Must be healthy (without medical, neurological, psychiatric illness)
  • Must be psychotropic medication free (≥ 14 days)

Exclusion Criteria:

  • Must not be a smoker
  • Females must not be pregnant or nursing
  • Must not suffer from claustrophobia
  • Must not meet exclusion criteria for MRI scanning (i.e., non-fixed magnetizable objects)
  • Must not have ongoing, chronic, or relapsing/remitting medical, psychiatric,or neurological illness as determined by a combination of history, medical record, and/or examination.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LIFUP sonication to the amygdala

Arm Description

Outcomes

Primary Outcome Measures

Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal
Changes in brain resting state functional network as indicated by fMRI scan connectivity measures

Secondary Outcome Measures

Change in performance on Reward Task
Tolerability of LIFUP sonication as assessed number of adverse events

Full Information

First Posted
January 3, 2022
Last Updated
April 15, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05194332
Brief Title
Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function
Official Title
Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
January 24, 2024 (Anticipated)
Study Completion Date
January 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to assess the low-intensity focused ultrasound pulsation (LIFUP) neuromodulation on emotion processing in healthy individuals, and to assess the overall safety of the LIFUP to stimulate or inhibit brain activity in healthy volunteers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
depression, mental illness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LIFUP sonication to the amygdala
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LIFUP sonication to the amygdala
Intervention Description
LIFUP sonication to amygdala will be performed.
Primary Outcome Measure Information:
Title
Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal
Time Frame
baseline, 5 mins post-LIFUP sonication
Title
Changes in brain resting state functional network as indicated by fMRI scan connectivity measures
Time Frame
baseline, 10-20 mins post-LIFUP sonication
Secondary Outcome Measure Information:
Title
Change in performance on Reward Task
Time Frame
baseline, 1-hour post-LIFUP sonication
Title
Tolerability of LIFUP sonication as assessed number of adverse events
Time Frame
baseline, immediately after LIFUP sonication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be right-handed Must be illicit drug-free at the time of scanning as appropriate (verified by negative urine drug screen) Must be healthy (without medical, neurological, psychiatric illness) Must be psychotropic medication free (≥ 14 days) Exclusion Criteria: Must not be a smoker Females must not be pregnant or nursing Must not suffer from claustrophobia Must not meet exclusion criteria for MRI scanning (i.e., non-fixed magnetizable objects) Must not have ongoing, chronic, or relapsing/remitting medical, psychiatric,or neurological illness as determined by a combination of history, medical record, and/or examination.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Boscutti, MD
Phone
713-486-2622
Email
Andrea.Boscutti@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jair Soares, MD, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Boscutti, MD
Phone
713-486-2622
Email
Andrea.Boscutti@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Juliana Figueiredo

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function

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