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WithdrawnNCT05194332Updated Feb 13, 2026

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

An interventional study of LIFUP sonication to the amygdala in Depressive Disorder, Major, sponsored by The University of Texas Health Science Center, Houston. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Basic science

Why this study was withdrawn
lack of resources and staff
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Depressive Disorder, Major

Keywords

  • depression
  • mental illness
03

In context

Depressive Disorder, Major

2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.

Browse Depressive Disorder, Major studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    LIFUP sonication to the amygdala

    Device: LIFUP sonication to the amygdala

Interventions

  • DeviceLIFUP sonication to the amygdala

    LIFUP sonication to amygdala will be performed.

06

What researchers measure

Primary outcomes

  1. 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

  2. Changes in brain resting state functional network as indicated by fMRI scan connectivity measures

    Time frame: baseline, 10-20 mins post-LIFUP sonication

Secondary outcomes

  1. Change in performance on Reward Task

    Time frame: baseline, 1-hour post-LIFUP sonication

  2. Tolerability of LIFUP sonication as assessed number of adverse events

    Time frame: baseline, immediately after LIFUP sonication

07

Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05194332
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Jair Soares (Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jan 18, 2022
Start date
Jan 1, 2026 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
Feb 13, 2026

Study contacts

Jair Soares, MD, PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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