The purpose of the study is to see that in addition to existing therapy, how well an additional procedure named spinal cord stimulation might reduce blood vessel spasm from aneurysm rupture.
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage (1)
Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage
Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5)
Does not provide consent for the procedure.
Posterior circulation aneurysmal subarachnoid hemorrhage.
Initial aneurysm treatment after post bleed day 1
Parallel
Vectris trial leads and stimulation
DeviceThe electrode is placed into the epidural space using standard epidural placement techniques with paramedian approach. The initial electrode settings have been adopted from prior studies. Should any significant discomfort be elicited from the stimulation, first the amplitude will be decreased to an acceptable level. If an acceptable level of stimulation is unable to be found, the stimulation will be discontinued.
Sham
DeviceNo electrode is placed.
Pre-Cerebrovascular response - Velocity
Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Pre-Cerebrovascular response - Resistance
Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Pre-Cerebrovascular response - Lindegaard ratio
Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Post-Cerebrovascular response - Velocity
Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Overall Survival
Overall survival is defined for all patients and measured from time of treatment to death or end of a study. The analyses for overall survival will be like that of the primary endpoint. It will also utilize Kaplan Meier methods and Cox proportional hazards modeling to compare the overall survival to the treatment-dependent prognosis index.
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