Depressive Disorder, MajorNCT05194332
Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function
A study testing LIFUP sonication to the amygdala in people with Depressive Disorder, Major, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- LIFUP sonication to the amygdala
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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.
- Conditions
- Depressive Disorder, Major
- Being tested
- LIFUP sonication to the amygdala
- Keywords
- depression, mental illness
- Medical subject headings
- Depressive Disorder, Major, Depression, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFUP sonication to the amygdalaDevice
LIFUP sonication to amygdala will be performed.
| Study group | Role | What they receive |
|---|---|---|
| LIFUP sonication to the amygdala | Experimental | Not described Receives: Device: LIFUP sonication to the amygdala |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in amygdala activity indicated by functional magnetic resonance imaging (fMRI) scan blood oxygen-level-dependent (BOLD) signal
Measured: baseline, 5 mins post-LIFUP sonication
Changes in brain resting state functional network as indicated by fMRI scan connectivity measures
Measured: baseline, 10-20 mins post-LIFUP sonication
Secondary outcomes (2)
Change in performance on Reward Task
Measured: baseline, 1-hour post-LIFUP sonication
Tolerability of LIFUP sonication as assessed number of adverse events
Measured: baseline, immediately after LIFUP sonication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Why it stopped: lack of resources and staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jair Soares, The University of Texas Health Science Center, Houston
- Investigators
- Jair Soares, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194332
- Sponsor's protocol ID
- HSC-MS-21-0570
- Status last verified
- Feb 2026
- First submitted
- 3 Jan 2022
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Low Intensity Focused Ultrasound Neuromodulation as a Probe to Study Human Emotion and Cognitive Function
- ClinicalTrials.gov ID
- NCT05194332
- Acronym / sponsor ID
- HSC-MS-21-0570
- Conditions
- Depressive Disorder, Major
- Keywords
- depression, mental illness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of resources and staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIFUP sonication to the amygdala | Experimental | Device: LIFUP sonication to the amygdala |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIFUP sonication to the amygdalaLIFUP sonication to amygdala will be performed. | Device | LIFUP sonication to the amygdala |
Primary outcome
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
Changes in brain resting state functional network as indicated by fMRI scan connectivity measures
Time frame: baseline, 10-20 mins post-LIFUP sonication
2 secondary outcomes
Change in performance on Reward Task
Time frame: baseline, 1-hour post-LIFUP sonication
Tolerability of LIFUP sonication as assessed number of adverse events
Time frame: baseline, immediately after LIFUP sonication
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jair Soares, MD, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIFUP sonication to the amygdala in people with Depressive Disorder, Major, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.