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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Vasospasm
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.
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
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Withdrawn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
No
5. Study Description
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.
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
No
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
background
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
background
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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