Low Intensity Focused Ultrasound: a New Paradigm for Depression and Anxiety
- Conditions
- Depression
- Registration Number
- NCT05147142
- Lead Sponsor
- Ocean State Research Institute, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria:<br><br> - Patients must meet DSM-5 criteria for major depressive disorder with and without<br> anxiety symptoms<br><br> - Patients must also be symptomatic (i.e. symptom severity above clinical thresholds<br> using standard rating scales) and, if relevant, stable treatment(s) for >6 weeks.<br><br>Exclusion Criteria:<br><br> - history of seizure disorder or serious neurologic illness including dementia<br><br> - structural or neurologic abnormalities present or in close proximity to sonication<br> site for patients (e.g., clinically significant calcification as might be observed<br> in Fahr disease)<br><br> - history of brain surgery, iv) pacemaker or implanted central nervous system device<br><br> - greater than mild traumatic brain injury, or any head injury within sixty days of<br> participation<br><br> - greater than moderate alcohol or substance use disorders (last six months; excluding<br> nicotine/caffeine)<br><br> - active use or withdrawal from alcohol or substances (assessed via breathalyzer/urine<br> testing as indicated)<br><br> - metal in the head<br><br> - impediment to vision, hearing and/or hand use likely to interfere with assessments<br><br> - pregnant or lactating (assessed via pregnancy test)<br><br> - unable to follow protocols<br><br> - acute suicidality, defined as Yes on item 4 of the Columbia Suicide Severity<br> Rating Scale (C-SSRS), (i.e., active suicidal ideation with some intent to act on<br> thoughts), or any endorsement of item 5 (active ideation with specific plan and<br> intent) or any actual, interrupted, aborted attempt or preparatory behavior within<br> the past month.<br><br> - symptom threshold considered in the very severe range using standard rating scales<br> will be excluded.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of LIFU-related adverse events as assessed by clinical MRI;Incidence of LIFU-related adverse events as assessed by neurological examinations;Incidence of LIFU-related adverse events as assessed by neuropsychological testing;BOLD fMRI Signal;Resting state functional connectivity;Perfusion Arterial Spin Labeling (ASL) fMRI Signal throughout Brain
- Secondary Outcome Measures
Name Time Method