2.1. Study Design
aneurysmal SAH, cerebral infarction, SAH, aneurysmal rupture
WEST, RECRUITMENT, CEREBRAL INFARCTION
TRIVASOSTIM is a single-center, randomized, double-blind prospective pilot study. It was designed to assess whether TENS applied to the trigeminal nerve (ophthalmic branch) decreases the risk of vasospasm-related cerebral infarction in patients with aneurysmal SAH compared with sham stimulation. Patients with aneurysmal rupture hospitalized for SAH in the Neurosurgery Department of Poitiers University Hospital were enrolled to participate in the study. Patients were included consecutively, without modifying the usual selection process. There was no difference in terms of quality and access to care between a patient who did or did not participate in the study during recruitment, the treatment process, or therapeutic follow-up. The study protocol was registered at Clinicaltrial.gov (number: NCT02482883) on 26 June 2015. The study was approved by the French Agency for the Safety of Health Products “ANSM” (number: 2016-A01144-47) as well as by the Ethics Committee “CPP West III”, and complied with the Declaration of Helsinki. Participants received explanations about the study procedures and provided written informed consent before enrolment in this study.