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NCT07166289 · ClinicalTrials.gov registry record · NA

Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression

A NA study of Treatment-Resistant Depression, sponsored by Laureate Institute for Brain Research.

Recruiting
Registry status
NA
Development phase
140
Enrollment target
1
Study location

NCT07166289: Recruiting NA study of Treatment-Resistant Depression, sponsored by Laureate Institute for Brain Research.

NCT07166289 is a NA study of Treatment-Resistant Depression that is actively recruiting participants, run by Laureate Institute for Brain Research. The registered enrollment target is 140 participants, below the 371-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07166289, a NA study of Treatment-Resistant Depression, is actively recruiting participants, sponsored by Laureate Institute for Brain Research.

RECRUITING
Registry status
NA
Development phase
140 participants
Enrollment target
1
Study location

Study Summary

Approximately one third of individuals with Major Depressive Disorder (MDD) are considered treatment-resistant, subject to severe disability and risk of suicide, and exhibit symptoms anchored in abnormalities of Research Domain Criteria (RDoC) Negative Valence Systems behavioral processes. In the present study we plan to use low-intensity focused ultrasound in 120 persons with treatment-resistant MDD to modulate deep white matter tracts connecting the thalamus and different regions of the prefrontal cortex reversibly and non-invasively, with the aim of assigning a causal, mechanistic role to large scale brain circuits in the production of those critical behavioral abnormalities. A successful study will help to attain the precise definition of neuromodulation targets for this clinical population in utter need of help.

Primary Outcome

Changes in resting-state functional (fMRI) connectivity (FC) between thalamus and either Anterior Cingulate (ACC) or Orbitofrontal (OFC) cortices after LIFU or Sham stimulation.

Interventions

  • OTHER Low-intensity focused ultrasound

Study Locations (1)

Oklahoma

  • Laureate Institute for Brain Research - Tulsa

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2025-09-30
Est. Completion 2030-07
Phase NA

What NCT07166289 shows while recruiting

NCT07166289 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 371-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (62% lower).

The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 1 intervention - of which Low-intensity focused ultrasound is the first listed.

NCT07166289 reports a single indexed study location in Oklahoma.

Frequently Asked Questions

What is clinical trial NCT07166289 about?

NCT07166289 is a clinical study titled "Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression". Approximately one third of individuals with Major Depressive Disorder (MDD) are considered treatment-resistant, subject to severe disability and risk of suicide, and exhibit symptoms anchored in abnormalities of Research Domain Criteria (RDoC) Negative Valence Systems behavioral processes. In the pr...

What is the current status of trial NCT07166289?

This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2025-09-30. Estimated completion is 2030-07.

What conditions does trial NCT07166289 study?

This clinical trial studies the following conditions: Treatment-Resistant Depression.

What interventions are being tested in trial NCT07166289?

The interventions under investigation include: Low-intensity focused ultrasound (OTHER).

Who is sponsoring clinical trial NCT07166289?

This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07166289 being conducted?

This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Treatment-Resistant Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07166289's enrollment target sits among peer trials

140 14th of 54 higher than 41 of 54 other Treatment-Resistant Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Treatment-Resistant Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07166289, the US trial registry maintained by the National Library of Medicine. NCT07166289 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.