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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Withdrawn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
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    First Posted
    April 22, 2015
    Last Updated
    March 20, 2018
    Sponsor
    Mayo Clinic
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    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
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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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