The primary objective of this study is to assess the safety and feasibility of FUS neuromodulation in participants with OUD and/or other SUDs.
This is an open-label early feasibility study investigating low intensity FUS targeting the NAc/VC for participants with OUD and/or other SUDs. Once participants are deemed eligible following Screening/Baseline, participants will undergo FUS in the bilateral NAc/VC with Behavioral and Substance Craving assessments performed prior to, during, and following the treatment. Participants will be assessed during follow-up visits on Day 1, Week 1, 4, 8, and 12.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
FUS Neuromodulation
WVU Rockefeller Neuroscience Institute
Morgantown, West Virginia, United States
Occurrence of Treatment Emergent Adverse Events
Incidence of Investigational procedure and device-related adverse Incidence of Investigational procedure and device-related adverse events and SAEs
Time frame: Beginning Day 0 (the day of the FUS procedure) through Week 4
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