Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Jacksonville, Florida 32224


Purpose:

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.


Study 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. 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.


Criteria:

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.


NCT ID:

NCT02426827


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Jacksonville, Florida 32224
United States

Scott Palmer
Phone: 904-956-3191
Email: Palmer.Scott@mayo.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.