Using focused ultrasound to treat depression and anxiety

Low Intensity Focused Ultrasound: a New Paradigm for Depression and Anxiety

This study is testing if low intensity focused ultrasound can safely help reduce symptoms of depression and anxiety in veterans.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 22 Years to 75 Years
• Sex: All
• Sponsor: Ocean State Research Institute, Inc. (other)
• Locations: 1 site (Providence, Rhode Island)
• Trial ID: NCT05147142 on ClinicalTrials.gov

What this trial studies

This study investigates the use of low intensity focused ultrasound (LIFU) as a non-invasive brain stimulation technique aimed at altering brain activity in regions associated with depression and anxiety. The primary goals are to assess the safety and tolerability of LIFU, evaluate its feasibility in reducing brain activity, and explore the simultaneous use of fMRI with LIFU. A total of 25 veterans will be recruited for this study, which will take place at the VA Providence Healthcare System. If successful, the findings could pave the way for innovative treatments for various psychiatric disorders.

Who should consider this trial

Good fit: Ideal candidates include veterans diagnosed with major depressive disorder, with or without anxiety symptoms, who are symptomatic and have stable treatment for over six weeks.

Not a fit: Patients with a history of seizure disorders, serious neurological illnesses, or those with certain structural abnormalities in the brain may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, non-invasive treatment option for patients suffering from depression and anxiety.

How similar studies have performed: While the use of focused ultrasound is a novel approach, preliminary studies suggest potential efficacy, but further validation is needed.

Eligibility criteria

Inclusion Criteria:

* Patients must meet DSM-5 criteria for major depressive disorder with and without anxiety symptoms
* Patients must also be symptomatic (i.e. symptom severity above clinical thresholds using standard rating scales) and, if relevant, stable treatment(s) for \>6 weeks.

Exclusion Criteria:

* history of seizure disorder or serious neurologic illness including dementia
* structural or neurologic abnormalities present or in close proximity to sonication site for patients (e.g., clinically significant calcification as might be observed in Fahr disease)
* history of brain surgery, iv) pacemaker or implanted central nervous system device
* greater than mild traumatic brain injury, or any head injury within sixty days of participation
* greater than moderate alcohol or substance use disorders (last six months; excluding nicotine/caffeine)
* active use or withdrawal from alcohol or substances (assessed via breathalyzer/urine testing as indicated)
* metal in the head
* impediment to vision, hearing and/or hand use likely to interfere with assessments
* pregnant or lactating (assessed via pregnancy test)
* unable to follow protocols
* acute suicidality, defined as "Yes" on item 4 of the Columbia Suicide Severity Rating Scale (C-SSRS), (i.e., active suicidal ideation with some intent to act on thoughts), or any endorsement of item 5 (active ideation with specific plan and intent) or any actual, interrupted, aborted attempt or preparatory behavior within the past month.
* symptom threshold considered in the "very severe" range using standard rating scales will be excluded.

Where this trial is running

Providence, Rhode Island

• VA Providence Healthcare System — Providence, Rhode Island, United States (RECRUITING)

Study contacts

• Principal investigator: Noah S Philip, MD — VA Providence Healthcare System
• Study coordinator: Noah S Philip, MD

Conditions: Depression, Functional Neuroimaging, Acoustic Stimulation, Focused Ultrasound