Status:
ACTIVE_NOT_RECRUITING
Focused Ultrasound Amygdala Neuromodulation
Lead Sponsor:
University of Texas at Austin
Conditions:
Depression
Anxiety Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of the study is to examine the feasibility and potential efficacy of low-intensity focused ultrasound as a method of modulating amygdala function to promote improvements in symptoms of an ...
Detailed Description
Affective disorders broadly defined, including the diagnoses of major depression, bipolar disorder, anxiety disorders, and posttraumatic stress disorder, constitute a large portion of the mental healt...
Eligibility Criteria
Inclusion
- Adults ages 18-65
- Willing and able to undergo the MRI and LIFUP procedures and repeated LIFUP for up to 15 sessions
- English language proficiency sufficient to speak to investigators and understand investigator instruction
- Can visit the laboratory several times over the course of 2 to 6 weeks
- Individuals with a primary affective disorder diagnosis (major depression, bipolar disorder, an anxiety disorder, or posttraumatic stress disorder on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders Diagnosis 5th Edition
- Score of 19 or greater on the general distress subscale of the 30-item Mood and Anxiety Symptom Questionnaire
- Psychiatric medication(s) on a stable dosage and regimen for the past 3 months (including antidepressants, mood stabilizers, atypical antipsychotics, and sedatives/hypnotics)
Exclusion
- Contraindications to LIFUP or MRI including, but not limited to, history of stroke, brain tumors, brain hemorrhages, internal wires, electrodes, pacemakers, implants, irremovable ferromagnetic objects in head that are unsafe for MRI and/or cause large distortions in imaging data, history of seizures (except febrile seizures in childhood), brain surgery, moderate-to-severe head injury or any penetrating head injury, and uncontrolled thyroid disorder.
- Pregnant women or people trying to become pregnant will also be excluded due to the unknown effects of MRI on developing fetuses
- Individuals with serious medical illnesses that are likely to interfere with study: cancer, autism, narcolepsy etc.
- Current active suicidal/homicidal ideation (or suicide attempt in the past 3 months)
- Current substance-use disorder
- Current or recent (within 3 months) psychotic symptoms, or currently meeting diagnostic criteria for a manic episode
- Individuals currently actively engaged in evidence-based or experimental treatments (e.g., weekly cognitive behavioral psychotherapies, transcranial magnetic stimulation, ketamine/esketamine treatment) other than psychiatric medication(s)
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05228964
Start Date
January 13 2022
End Date
December 31 2024
Last Update
December 6 2024
Active Locations (1)
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1
Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600
Austin, Texas, United States, 78712