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Cervical Spinal Cord Stimulation in Cerebral Vasospasm (SCSinCV)

Primary Purpose

Cerebral Vasospasm

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Spinal Cord Stimulation

About this trial

This is an interventional treatment trial for Cerebral Vasospasm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCS in CV

Arm Description

Outcomes

Primary Outcome Measures

Looking at number of patients without an adverse effect

Secondary Outcome Measures

Full Information

NCT ID

NCT02426827

First Posted

April 22, 2015

Last Updated

March 20, 2018

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02426827

Brief Title

Cervical Spinal Cord Stimulation in Cerebral Vasospasm

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of funding

Study Start Date

July 2016 (undefined)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Vasospasm

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SCS in CV

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Spinal Cord Stimulation

Primary Outcome Measure Information:

Title

Looking at number of patients without an adverse effect

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott C Palmer, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

19409714

Citation

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.

Results Reference

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PubMed Identifier

17995571

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. doi: 10.1111/j.1526-4637.2007.00388.x. No abstract available.

Results Reference

background

PubMed Identifier

3879799

Citation

Hosobuchi Y. Electrical stimulation of the cervical spinal cord increases cerebral blood flow in humans. Appl Neurophysiol. 1985;48(1-6):372-6. doi: 10.1159/000101161.

Results Reference

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PubMed Identifier

1705326

Citation

Hosobuchi Y. Treatment of cerebral ischemia with electrical stimulation of the cervical spinal cord. Pacing Clin Electrophysiol. 1991 Jan;14(1):122-6. doi: 10.1111/j.1540-8159.1991.tb04056.x.

Results Reference

background

PubMed Identifier

10927901

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. doi: 10.2176/nmc.40.352.

Results Reference

background

PubMed Identifier

18500217

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.

Results Reference

background

PubMed Identifier

20648204

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.

Results Reference

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PubMed Identifier

15109517

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. doi: 10.1016/j.pain.2003.12.016.

Results Reference

background

PubMed Identifier

21345703

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.

Results Reference

background

PubMed Identifier

11588316

Citation

Lysakowski C, Walder B, Costanza MC, Tramer 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. doi: 10.1161/hs1001.097108.

Results Reference

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Cervical Spinal Cord Stimulation in Cerebral Vasospasm

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