Cervical Spinal Cord Stimulation in Cerebral Vasospasm
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | December 2015 |
| End Date: | April 2018 |
A Safety and Feasibility Study of the Use of Cervical Spinal Cord Stimulation for Treatment of Cerebral Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage
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.
for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence
of cerebral vasospasm.
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.
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.
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.
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