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

Launched by OCEAN STATE RESEARCH INSTITUTE, INC. · Nov 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called low intensity focused ultrasound (LIFU) to see if it can help reduce symptoms of depression and anxiety. LIFU is a non-invasive technique that uses sound waves to target specific areas of the brain that are often hard to reach with current treatments. The trial aims to test how safe and tolerable this method is, and whether it can actually change brain activity related to these mental health conditions.

To participate, you must be a veteran aged between 18 and 70 who meets the criteria for major depressive disorder, with or without anxiety symptoms. You should also be experiencing significant symptoms and have been stable on any current treatments for at least six weeks. If you join the study, you would attend several visits over about six weeks, during which some sessions will involve the LIFU treatment. Throughout the trial, researchers will monitor your health and safety closely. This study could pave the way for new and innovative treatments for depression and anxiety in the future.

Gender

ALL

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.