Low Intensity Focused Ultrasound for Posttraumatic Stress Disorder
VA Office of Research and Development
Summary
The goal of this study is to develop a new, non-invasive brain stimulation modality called low intensity focused ultrasound (FUS) as a psychiatric rehabilitation treatment for posttraumatic stress disorder (PTSD). FUS delivers energy comparable to that involved in diagnostic ultrasound but in a millimeter-sized envelope. Unlike currently available methods, the maximal FUS energy is delivered at a distance from a transducer on the scalp. Therefore, its promise is that it can deliver focal and reversible modulation to deeper brain regions involved in PTSD. The investigator team has previously conducted first-in-human research in FUS, and this study builds upon that work to conduct a phase II, dose-finding study. This study will pursue two Aims; the first is whether FUS to the amygdala can improve symptoms, and the second will evaluate whether FUS improves function by reduced disability, over a 1-month period. Short and longer-term effects of FUS will be measured and all FUS parameters are within FDA-defined safety thresholds for diagnostic ultrasound.
Description
PTSD is highly prevalent in Veterans and is associated with significant psychiatric and medical comorbidity and healthcare utilization. Most importantly, PTSD prevents Veterans from reintegrating into society and is associated with significant disability and psychosocial dysfunction. Despite its prevalence and devastating impact, even the most efficacious treatments have modest success in improving either symptoms or functioning in Veterans with PTSD. One reason for this limited efficacy is the inability for current treatments to directly target and engage deep brain regions which are directly…
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: -Veterans ages 22-70 (inclusive) who meet DSM-5 criteria for chronic PTSD using the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and currently symptomatic. If applicable, Veterans will be required to be on stable psychiatric treatment(s) prior to baseline assessments Exclusion Criteria: * contraindications to focused ultrasound and/or neuroimaging: * i) history of seizure disorder or serious neurologic illness including dementia or serious cognitive impairment, * ii) structural or neurologic abnormalities present or in close proximity to sonication site ,…
Interventions
- DeviceBrainsonix Ultrasound Device
This device delivers low intensity focused ultrasound and delivers either active or sham sonication depending upon the transducer pad used.
Location
- Providence VA Medical Center, Providence, RIProvidence, Rhode Island