Cervical Spinal Cord Stimulation in Cerebral Vasospasm

Cerebral Vasospasm Clinical Trial

— SCSinCV  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02426827
• Other study ID #: 14-007493
• Status: Withdrawn
• Phase: N/A
• First received: April 22, 2015
• Last updated: March 20, 2018
• Start date: July 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Vasospasm
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

Device:
• Spinal Cord Stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

References & Publications (10)

Goellner E, Slavin KV. Cervical spinal cord stimulation may prevent cerebral vasospasm by modulating sympathetic activity of the superior cervical ganglion at lower cervical spinal level. Med Hypotheses. 2009 Sep;73(3):410-3. doi: 10.1016/j.mehy.2009.01.055. Epub 2009 May 5. — View Citation

Hosobuchi Y. Electrical stimulation of the cervical spinal cord increases cerebral blood flow in humans. Appl Neurophysiol. 1985;48(1-6):372-6. — View Citation

Hosobuchi Y. Treatment of cerebral ischemia with electrical stimulation of the cervical spinal cord. Pacing Clin Electrophysiol. 1991 Jan;14(1):122-6. — View Citation

Lysakowski C, Walder B, Costanza MC, Tramèr MR. Transcranial Doppler versus angiography in patients with vasospasm due to a ruptured cerebral aneurysm: A systematic review. Stroke. 2001 Oct;32(10):2292-8. — View Citation

North R, Shipley J, Prager J, Barolat G, Barulich M, Bedder M, Calodney A, Daniels A, Deer T, DeLeon O, Drees S, Fautdch M, Fehrenbach W, Hernandez J, Kloth D, Krames ES, Lubenow T, North R, Osenbach R, Panchal SJ, Sitzman T, Staats P, Tremmel J, Wetzel T, American Academy of Pain Medicine. Practice parameters for the use of spinal cord stimulation in the treatment of chronic neuropathic pain. Pain Med. 2007 Dec;8 Suppl 4:S200-75. — View Citation

Pluijms WA, Slangen R, Joosten EA, Kessels AG, Merkies IS, Schaper NC, Faber CG, van Kleef M. Electrical spinal cord stimulation in painful diabetic polyneuropathy, a systematic review on treatment efficacy and safety. Eur J Pain. 2011 Sep;15(8):783-8. doi: 10.1016/j.ejpain.2011.01.010. Epub 2011 Feb 22. Review. — View Citation

Smith CC, Lin JL, Shokat M, Dosanjh SS, Casthely D. A report of paraparesis following spinal cord stimulator trial, implantation and revision. Pain Physician. 2010 Jul-Aug;13(4):357-63. — View Citation

Takanashi Y, Shinonaga M. Spinal cord stimulation for cerebral vasospasm as prophylaxis. Neurol Med Chir (Tokyo). 2000 Jul;40(7):352-6; discussion 356-7. — View Citation

Turner JA, Loeser JD, Deyo RA, Sanders SB. Spinal cord stimulation for patients with failed back surgery syndrome or complex regional pain syndrome: a systematic review of effectiveness and complications. Pain. 2004 Mar;108(1-2):137-47. Review. — View Citation

Visocchi M. Neuromodulation of cerebral blood flow by spinal cord electrical stimulation: the role of the Italian school and state of art. J Neurosurg Sci. 2008 Jun;52(2):41-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Looking at number of patients without an adverse effect		7 days