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Clinical Feasibility of Low Intensity Focused Ultrasound Pulsation for the Treatment of Treatment Resistant Major Depressive Disorder
The Investigators are proposing to demonstrate safety and efficacy of LIFUP for treatment resistant major depressive disorder in a ten-patient pilot study. LIFUP is an emerging treatment with the advantage of being able to target subcortical transcranial targets, which may have superior efficacy or a shorter treatment course compared to other available treatments such as transcranial magnetic stimulation. This study will investigate the effect of this stimulation on the left subgenual cingulate cortex, a highly connected node in the depression network that is correlated with clinical symptomatology.
The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low intensity focused ultrasound pulsation (LIFUP) for treatment resistant depression (TRD). Participants will receive either LIFUP or sham stimulation with crossover of sham participants into the treatment group halfway through the treatment course. The initial visit will involve consent and an MRI scan, followed by several more either active or sham treatments outside of the MRI environment delivered over the course of two days over one week. Response and potential side effects will be monitored pre- and post- each treatment along with one week and one month follow-up assessments.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
30 Bee Street
Charleston, South Carolina, United States
Start Date
February 16, 2024
Primary Completion Date
June 1, 2028
Completion Date
June 1, 2028
Last Updated
January 12, 2026
1
ACTUAL participants
Low-Intensity Focused Ultrasound Pulsation
DEVICE
Sham Low-Intensity Focused Ultrasound Pulsation
DEVICE
Lead Sponsor
Medical University of South Carolina
NCT07115329
NCT06793397
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07025720