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Trial record 20 of 799 for:    cervical AND Brain

Cervical Spinal Cord Stimulation in Cerebral Vasospasm (SCSinCV)

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ClinicalTrials.gov Identifier: NCT02426827
Recruitment Status : Withdrawn (Lack of funding)
First Posted : April 27, 2015
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Scott C. Palmer, M.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Cerebral Vasospasm Device: Spinal Cord Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Arm Intervention/treatment
Experimental: SCS in CV Device: Spinal Cord Stimulation



Primary Outcome Measures :
  1. Looking at number of patients without an adverse effect [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426827


Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Scott C Palmer, MD Mayo Clinic

Publications:

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Responsible Party: Scott C. Palmer, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02426827     History of Changes
Other Study ID Numbers: 14-007493
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Brain Diseases
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Intracranial Hemorrhages
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhage
Pathologic Processes