Focused Ultrasound Amygdala Neuromodulation

Launched by UNIVERSITY OF TEXAS AT AUSTIN · Jan 26, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help people with depression, anxiety disorders, bipolar depression, and PTSD (post-traumatic stress disorder) using a technique called low-intensity focused ultrasound. This method uses ultrasound waves, similar to those used in pregnancy scans, to target a specific part of the brain called the amygdala, which plays a role in emotions. The goal is to see if this treatment can improve symptoms for those struggling with these mental health conditions. Participants will undergo this treatment once a day, five days a week, for three weeks, while also having brain scans to ensure the procedure is being done accurately.

To be eligible for the trial, participants must be adults aged 18 to 65 who have been diagnosed with one of the mentioned affective disorders and are stable on their psychiatric medications for at least three months. They should be able to attend multiple visits over two to six weeks and communicate in English. However, people with certain medical conditions, a history of severe mental health issues, or those who are pregnant cannot participate. This trial is currently active but not recruiting new participants, so it’s important to check back for updates if you or someone you know is interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)