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

NCT ID: NCT05194332

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorder, Major

Keywords

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depression mental illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LIFUP sonication to the amygdala

Group Type EXPERIMENTAL

LIFUP sonication to the amygdala

Intervention Type DEVICE

LIFUP sonication to amygdala will be performed.

Interventions

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LIFUP sonication to the amygdala

LIFUP sonication to amygdala will be performed.

Intervention Type DEVICE

Eligibility Criteria

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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 have ongoing, chronic, or relapsing/remitting medical, psychiatric,or neurological illness as determined by a combination of history, medical record, and/or examination.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jair Soares

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jair Soares, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Andrea Boscutti, MD

Role: CONTACT

Phone: 713-486-2622

Email: [email protected]

Facility Contacts

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Andrea Boscutti, MD

Role: primary

Juliana Figueiredo

Role: backup

Other Identifiers

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HSC-MS-21-0570

Identifier Type: -

Identifier Source: org_study_id