Cervical Spinal Cord Stimulation in Cerebral Vasospasm

Not Applicable

Withdrawn

• Conditions: Cerebral Vasospasm
• Interventions: Device: Spinal Cord Stimulation

• Registration Number: NCT02426827
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-04-24
• Study First Posted: 2015-04-27
• Study Start: 2016-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCS in CV	Spinal Cord Stimulation	-

Primary Outcome Measures

Name	Time	Method
Looking at number of patients without an adverse effect	7 days