Cervical Spinal Cord Stimulation in Cerebral Vasospasm

Study Overview
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Brief Summary
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The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS) for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm.

Detailed Description
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The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS) for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm. Stimulation will be provided with electrodes placed percutaneously in the upper cervical epidural space. The outcome of 5 patients will be studied with focus on possible adverse events related to the intervention. Vasospasm response to treatment will be measured as a secondary outcome. Middle cerebral artery flow velocity will be followed by transcranial Doppler and clinical outcome measured by NIH stroke scale. Flow velocities will be monitored daily by transcranial Doppler and NIH stroke scale performed daily for 7 days, after which spinal cord stimulation will be discontinued and the epidural lead removed.

Official Title
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A Safety and Feasibility Study of the Use of Cervical Spinal Cord Stimulation for Treatment of Cerebral Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage

Conditions
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Cerebral Vasospasm

Intervention / Treatment
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* Device: Spinal Cord Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a history of aneurysmal subarachnoid hemorrhage and will have aneurysm secured by clipping or coiling. evidence of vasospasm on TCD with MCA mean flow velocity >120 cm/s. Patients must be clinically stable to leave the ICU for the study intervention. Patients will have Hunt and Hess grade 1-2 non-traumatic subarachnoid hemorrhage. Patient should be oriented patients able to provide informed consent. Exclusion Criteria: Patients with non-aneurysmal hemorrhage Patient with coagulopathy (PTT>40, or INR > 1.2) thrombocytopenia (platelets <100 x 103 per mm2). Use of anticoagulation or antiplatelet medication within the known clinical effective period of the particular medication. allergy to nimodipine. History of cervical or thoracic spine surgery. Skin infection at site of catheter placement. Sepsis. Pregnancy. Age less than 18 or greater than 80. Active diagnosis of cancer or history of metastatic cancer. Presence of cardiac defibrillator. Inability or unwillingness of patient to give informed consent. Patients found to be clinically neurologically unstable, hemodynamically unstable, or suffering from unstable intracranial pressure at the time of assessment for lead placement will not have the intervention.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCS in CV<br> | Device: Spinal Cord Stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Looking at number of patients without an adverse effect |  | 7 days |