Development of Low-Intensity Focused Ultrasound for Post Traumatic Brain Injury Depression
- NCT ID
- NCT07828483
- Registry status
- Not yet recruiting
- Study type
- Not specified in the registry data
- Phase
- Not applicable
- Sponsor
- Stanford University
Overview
ClinicalTrials.gov lists this study as Not yet recruiting.
Enrollment: 25 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
1. Adult Veteran, male or female, 22 to 55 years of age at the time of screening.
2. 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.
3. 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.
4. The TBI must have occurred at least 3 months before the occurrence of depression
5. Current depressive disorder defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
6. Medical records confirming a history of moderate to severe treatment-resistance as defined by a score of 7-14 on the Maudsley Staging Method (MSM3).
7. MADRS score of ≥20 at screening.
8. Total duration of current depressive episode is less than 2 years
9. LIFU naive.
10. Access to ongoing psychiatric care before and after completion of the study.
11. The dose of the primary antidepressant medication must be stable for 6 weeks prior to baseline , and participants must agree to continue at this dose throughout the study period.
12. In good general health, as evidenced by medical history.
13. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to baseline and agreement to use such a method during study participation.
14. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.
Exclusion Criteria:
1. 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.
2. Pregnancy
3. Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder
4. History of or current psychotic disorder or bipolar disorder
5. Severe borderline personality disorder.
6. Diagnosis of Intellectual Disability or Autism Spectrum Disorder
7. Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
8. Urine screening test positive for illicit substances
9. Active suicidal ideation (defined as an MSSI \> 8) or a suicide attempt (as defined by the C-SSRS) within the past one year
10. Cognitive impairment (defined as MoCA \< 23)
10\. Any history of ECT without meeting responder criteria 11. Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., ketamine or a course of ECT) 12. History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma, or multiple sclerosis 13. Untreated or insufficiently treated endocrine disorder. 14. Contraindication to receiving LIFU 15. Contraindication to MRI (ferromagnetic metal in their body) 16. Treatment with another investigational drug or other intervention within the study period 17. Unstable symptoms between screening and baseline as defined by a \> 30% change in MADRS-S score.
18\. Any other condition deemed by the PD to interfere with the study or increase risk to the participant
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: United States
- California, United States: 1
Sample of listed locations
- Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine — Stanford, California, 94305, United States — Site recruitment status not specified in the registry data
Study details
- Start date
- November 1, 2026
- Primary completion date
- December 31, 2028
- First posted
- September 18, 2026
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT07828483
- Registry last updated
- September 18, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT07828483 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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