Study design
This study is a randomized, sham-controlled, patient and assessor-blinded trial. The study protocol was approved by the institutional review board at the University of California, Irvine (UCI) and via reliance agreement with Children’s Hospital of Orange County (CHOC) and their institution’s respective institution review board (IRB). The protocol has been registered at ClinicalTrials.gov (NCT05283577). A total of 64 patients will be randomly assigned to a vEA or a sEA group in a 1:1 ratio. Forty of the 64 recruited participants will be recruited for the optional neuroimaging sub-study.