Cervical spinal cord stimulation for prevention and treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage: clinical and radiographic outcomes of a prospective single-center clinical pilot study.

BACKGROUND

Cerebral vasospasm induced by aneurysmal subarachnoid hemorrhage (aSAH) is a major cause of high morbidity and mortality, for which there is no consistently effective treatment. Cervical spinal cord stimulation (cSCS) has been shown to induce vasodilatation and improve peripheral and cerebral blood flow in both animal and human studies. This pilot study was performed to assess the clinical effect and long-term results of cSCS treatment in aSAH patients.

METHODS

This was the first IRB- and US FDA-approved prospective non-randomized non-controlled study comprising of 12 aSAH patients (8 women, 4 men, age range 34-62 years) treated between May and November 2008. All patients underwent up to 2 weeks of cSCS with a single percutaneously implanted 8-contact electrode. Neurological outcomes at discharge and follow-up of up to 13 years and mortality/complications rates were analyzed.

RESULTS

All 12 aSAH patients underwent cSCS electrode implantation immediately after securing the aneurysm. Patients were stimulated for 10-14 consecutive days starting within 3 days of aneurysm rupture. Angiographic vasospasm occurred in six patients; two patients developed new vasospasm-related neurological symptoms; both recovered completely by discharge time. One patient died from unrelated multi-system failure; the rest were followed up clinically (average, 7.5 years; range, 12-151 months) and angiographically (average, 6.5 years; range, 36-125 months). No delayed ischemic neurological deficits/strokes and no cSCS-related adverse effects were observed.

CONCLUSIONS

Our short- and long-term data suggest that cSCS is feasible and safe for patients in the acute aSAH settings. Small size of the patient cohort and lack of control do not allow us to conclude whether cSCS is able to prevent cerebral vasospasm, decrease its severity, and improve clinical outcomes in aSAH patients. However, our findings support further clinical trials and development of cSCS as a new concept to prevent and treat cerebral vasospasm.

CLINICALTRIALS

gov NCT00766844, posted on 10/06/2008.