2.5. Study Endpoints
death, functional disability, Functional disability, vasospasm, aneurysmal SAH, cerebral infarction, DCI, infarction
DELAYED CEREBRAL ISCHEMIA, PCT, ADVERSE EVENTS, VASOSPASM, SENSITIVITY, SECONDARY, DCI, CEREBRAL INFARCTION, MRS, INFARCTION
The primary objective was to determine whether TNS decreases the incidence of cerebral infarction related to vasospasm in patients with aneurysmal SAH compared to sham stimulation at a 3-month follow-up.Treatment efficacy was assessed by the presence of cerebral infarction on MRI FLAIR at 3 months or on the last CT/MRI scan before death, after exclusion of infarcts from other causes (procedure-related, hematoma-related, etc.) as a primary or relevant cause, or considered not exclusively due to causes other than vasospasm.The secondary objectives were to compare the degree of functional disability between the two groups at 6 months; to analyze the tolerance of transcutaneous trigeminal system stimulation by means of a collection of adverse events; to compare mortality between groups; and to detect a perfusion abnormality on the perfusion scan performed at D6 of inclusion. We also evaluated the relationship between perfusion abnormalities, WFNS grade and vasospasm occurrence.Functional disability was assessed using the Modified Rankin Scale (MRS) and Glasgow Outcome Scale (GOS). This represented the proportion of patients with an unfavorable outcome as follows: MRS ≥ 3 at 6 months. Other collected secondary evaluation criteria were spontaneously reported adverse events and/or notification of intercurrent pathologies; the collection of CT scans at admission, control and perfusion scans at D6; the collection of morphological MRI with FLAIR sequences; the concomitant treatments; the causes of death during the study. Regarding cerebral perfusion assessment, the radiologic criterion was a perfusion abnormality (at D6) detected on PCT. This corresponded to the proportion of patients at risk of developing delayed cerebral ischemia (DCI) at D6 assessed by PCT in a previous feasibility evaluation. An average transit time (ATT) prolongation of more than 1.2 s between hypoperfused and healthy vascular territories on PCT performed at D6 post-SAH was predictive of DCI (infarction at 3 months on MRI) with or without vasospasm (specificity of 92.3% and sensitivity of 100%). Sensitivity and specificity were 95% and 100%, respectively, for predicting the risk of DCI by visual analysis of ATT and time-to-peak maps, with more focus on the junctional territories. Safety was assessed based on the rates of adverse events and serious adverse events.