2.4. Study Protocol and Data Collection
bleeding, Coma, hemorrhagic, paresthesia, hydrocephalus, cerebral aneurysm
BLEEDING, PCT, COMA, PARESTHESIA, HYDROCEPHALUS, SECONDARY, CEREBRAL ANEURYSM
Patient randomization was considered at D1 for patients, during which a clinical exam was performed and the following baseline data were collected: sociodemographic data, patient and patient family past medical history, current and past addictions, current medications, the time interval between bleeding and hospital admission, and World Federation of Neurosurgical Societies (WFNS) grade. Qualitative information was collected after the completion of imaging to document hemorrhagic distribution, diagnostic method, cerebral aneurysm characteristics, radiologic hydrocephalus criteria and cerebral vessel characteristics.Patients were hospitalized in the neurosurgical intensive care unit if their WFNS grade was higher than 2, and otherwise in a conventional neurosurgical unit.TENS electrodes were placed for all patients over the innervation territory of the supra-trochlear and supra-orbital nerves. After paresthesia threshold determination and randomization, stimulation was continuously applied 24 h per day for 10 days in the TNS group. Stimulation frequency was 20 Hz. Clinical surveillance and Glasgow Coma Scale calculations were performed multiple times per day. Any clinical pre- or post-procedural degradation prompted additional clinical examinations and a CT scan. All these data were collected in an observation book.On the 6th day (D6), all patients had a perfusion CT scan (PCT) (At month 3 (M3 ± 3 weeks), patients underwent a clinical exam, magnetic resonance imaging (MRI) scan with fluid-attenuated inversion recovery (FLAIR), and data on reported secondary effects, intercurrent pathologies and treatments were collected.At 6 months (M6 ± 4 weeks), patients underwent clinical evaluation, and data were collected on reported secondary effects, intercurrent pathologies and treatments.