Development of Low-Intensity Focused Ultrasound for Post Traumatic Brain Injury Depression

ConditionsPost-traumatic Brain Injury Depression Veteran Health

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22-55

SponsorStanford University

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult Veteran, male or female, 22 to 55 years of age at the time of screening.

Able to read, understand, and provide written, dated informed consent before initiation of formal study screening procedures. A brief IRB-approved telephone pre-screen may be conducted prior to written informed consent as described in Section 8.1. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and LIFU interventions. Stated 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.

History of non-penetrating mild to moderate TBI confirmed by medical records and adjudicated by the study investigator using established TBI criteria (e.g., ACRM/VA-DoD criteria). If contemporaneous records are incomplete, a structured lifetime TBI interview may be used to support classification.

The TBI must have occurred at least 3 months before the occurrence of depression

Disqualifiers

Any lifetime DSM-5 depressive disorder or clinically significant depressive episode with onset prior to the qualifying index TBI, including major depressive disorder, persistent depressive disorder, or other specified/unspecified depressive disorder, or any antidepressant treatment initiated for depression prior to the index TBI.

Pregnancy

Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder

History of or current psychotic disorder or bipolar disorder

Trial design

Design model

Parallel

Treatments tested in this trial

Active Low-Intensity Focused Ultrasound (LIFU)
Device
MRI-guided Low-Intensity Focused Ultrasound (LIFU) neuromodulation targeting the sgACC delivered over a brief, intensive course (20-minute sessions; 5 sessions/day for 5 consecutive days).
Sham Low-Intensity Focused Ultrasound (LIFU)
Other intervention
Non-active MRI-guided Low-Intensity Focused Ultrasound (LIFU) neuromodulation targeting the sgACC delivered over a brief, intensive course (20-minute sessions; 5 sessions/day for 5 consecutive days).

Treatment groups

25 Participants

are divided into 2 treatment groups

Group A: Active Low-Intensity Focused Ultrasound (LIFU)Active comparator 1 intervention

Group B: Sham Low-Intensity Focused Ultrasound (LIFU)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

To evaluate the safety and tolerability of repeated sgACC-targeted LIFU stimulation in adult Veterans with PTD.

Cumulative incidence of treatment-emergent adverse events and serious adverse events.

Time frame

Baseline, Treatment Days 1 through 5, 1-Week, 1-2:4-week follow up visits.

Secondary outcomes

To evaluate the preliminary antidepressant efficacy of repeated sgACC-targeted LIFU in adult Veterans with PTD.

Absolute change from baseline in the MADRS total score.

Time frame

Baseline, 1-week follow up, 4-week follow up

Other outcomes

To characterize changes in neuroimaging measures associated with LIFU.

Change from baseline in prespecified resting-state fMRI measures of sgACC-centered functional connectivity and depression-related network connectivity.

Time frame

Baseline and 1-week follow-up

To characterize changes in electrophysiologic measures associated with LIFU.

Change from baseline in prespecified resting-state and LIFU-associated EEG measures of neural activity and functional connectivity.

Time frame

Baseline, treatment days 1 through 5 and 1-week follow-up

To evaluate whether baseline fMRI feature predict clinical response to LIFU.

Associations between baseline fMRI features and absolute change from baseline in MADRS total score.

Time frame

Baseline, 1-week follow up and 4-week follow up visits

To evaluate whether baseline EEG features predict clinical response to LIFU.

Associations between baseline EEG features and absolute change from baseline in MADRS total score.

Time frame

Baseline, 1-week follow up and 4-week follow up visits

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

VA Palo Alto Health Care System

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: