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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

  • Original Article - Functional Neurosurgery - Other
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Abstract

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.

Trial registration.

ClinicalTrials.gov NCT00766844, posted on 10/06/2008.

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Abbreviations

ACA:

Anterior cerebral artery

aSAH:

Aneurysmal subarachnoid hemorrhage

BA:

Basilar artery

cSCS:

Cervical spinal cord stimulation

CT:

Computed tomography

DIND:

Delayed ischemic neurological deficit

DSA:

Digital subtraction angiography

ICA:

Internal carotid artery

IRB:

Institutional Review Board

LR:

Lindegaard ration

MCA:

Middle cerebral artery

POD:

Postoperative day

SAH:

Subarachnoid hemorrhage

SCS:

Spinal cord stimulation

TCD:

Transcranial Doppler

US FDA:

United States Food and Drug Administration

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Acknowledgements

The authors want to thank Drs. F.T. Charbel, S. Amin-Hanjani, R. Deveshwar, V. Aletich, A.M. Alaraj, E. Goellner, S. Aydin, P. Eboli, P.H. Krishna, D. Yin, N. Mlinarevich, K.S. Watson, L.E. Walters, and other attending neurosurgeons, residents, fellows, nurses, and clinical research personnel from the Department of Neurosurgery at the University of Illinois at Chicago who contributed to the successful completion of this multi-year study and Ms. Christa Wellman for creation of the anatomical illustration.

Funding

The entire project was investigator-initiated and funded.

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Contributions

Both authors whose names appear on the submission (1) made substantial contributions to the conception or design of the work; the acquisition, analysis, or interpretation of data; or the creation of new software used in the work; (2) drafted the work or revised it critically for important intellectual content; (3) approved the version to be published; and (4) agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Konstantin V. Slavin.

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The authors confirm that the study was approved by the appropriate institutional research ethics committee (University institutional review board—protocol # 2007–0899) and certify that the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Consent to participate

Freely given informed consent to participate in the study was obtained from participants, or the family if the patient for medical reasons was unable to, by signing an IRB-approved informed consent forms.

Conflict of interest

The principal investigator and the institution have an issued US Patent (# 8,494,638 B2) covering the topic of this research. The principal author and/or institution have received financial support for unrelated research and/or educational projects from Abbott, Medtronic, and Boston Scientific.

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Slavin, K.V., Vannemreddy, P. 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. Acta Neurochir 164, 2927–2937 (2022). https://doi.org/10.1007/s00701-022-05325-4

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