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Low-Intensity Focused Ultrasound for Depression

MW
JP
Overseen ByJohn P Coetzee, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn about evaluate the safety, tolerability, and feasibility of MRI-guided LIFU targeting the sgACC in Veterans with post-traumatic brain injury depression. The main questions it aims to answer are:

1. the safety, tolerability, and feasibility of MRI-guided LIFU.

2. Evaluate preliminary antidepressant efficacy.

3. Characterize target engagement using multimodal neuroimaging and electrophysiology.

4. Identify imaging and electrophysiological biomarkers that predict treatment response.

5. Generate preliminary effect size estimates to support future multicenter clinical trials.

Who Is on the Research Team?

MB

Mahendra Bhati, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for veterans who have depression after a traumatic brain injury. Participants should also have symptoms of post-traumatic stress disorder (PTSD).

Inclusion Criteria

Willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information
Medical records confirming a history of moderate to severe treatment-resistance defined by a score of 7-14 on the Maudsley Staging Method (MSM3)
MADRS score of ≥20 at screening
See 13 more

Exclusion Criteria

Diagnosis of Intellectual Disability or Autism Spectrum Disorder
History of or current psychotic disorder or bipolar disorder
Current moderate or severe substance use disorder or signs of acute substance withdrawal
See 16 more

What Are the Treatments Tested in This Trial?

Interventions

  • Low-Intensity Focused Ultrasound (LIFU)

Trial Overview

The study compares real low-intensity focused ultrasound (LIFU) treatment to a sham (inactive) version, both guided by MRI and aimed at a specific brain area linked to mood regulation.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active Low-Intensity Focused Ultrasound (LIFU)Active Control1 Intervention
Group II: Sham Low-Intensity Focused Ultrasound (LIFU)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

VA Palo Alto Health Care System

Collaborator

Trials
97
Recruited
58,500+

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