Cerebral Vasospasm Clinical Trial
— SCSinCVOfficial 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
Verified date | March 2018 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Looking at number of patients without an adverse effect | 7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02275949 -
Acupuncture for Cerebral Vasospasm After Subarachnoid Hemorrhage
|
N/A | |
Completed |
NCT02389634 -
Identification of Novel Molecular Markers for Vasospasm
|
||
Completed |
NCT00962546 -
Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
|
N/A | |
Not yet recruiting |
NCT04512859 -
Stellate Ganglion Block in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
|
N/A | |
Completed |
NCT01024972 -
Safety Study of Dantrolene in Subarachnoid Hemorrhage
|
Phase 1/Phase 2 | |
Completed |
NCT00692744 -
Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH)
|
N/A | |
Completed |
NCT04208477 -
"The Effect of Stellate Ganglion Block in Severe Brain Injury"
|
N/A | |
Recruiting |
NCT06303349 -
Predictive Model for the Occurrence of Cerebral Vasospasm Complicating Subarachnoid Haemorrhage by Combined Analysis of the Kinetics of a Panel of Biomarkers.
|
N/A | |
Recruiting |
NCT02129413 -
Safety Study of Carotid Body Neurostimulation to Treat Cerebral Vasospasm
|
N/A | |
Terminated |
NCT00582868 -
Use of Brain Oxygen Tension Level and Cleaved-tau Protein to Detect Vasospasm After SAH
|
N/A | |
Terminated |
NCT00487461 -
Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage
|
N/A | |
Withdrawn |
NCT01878136 -
Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
|
Phase 1/Phase 2 | |
Withdrawn |
NCT01091870 -
Sildenafil for Prevention of Cerebral Vasospasm
|
Phase 2 | |
Completed |
NCT03214705 -
Role of CT Perfusion in Predicting Poor Outcome After Subarachnoid Hemorrhage
|
||
Recruiting |
NCT05150002 -
Cervical Spinal Cord Stimulation in Patients With Cerebral Vasospasm After Subarachnoid Haemorrhage: VasoStim Study
|
N/A | |
Completed |
NCT01187420 -
Bilateral Bispectral Index (BIS) Study
|
N/A | |
Enrolling by invitation |
NCT05230134 -
Cervical Sympathetic Block in Patients With Cerebral Vasospasm
|
N/A | |
Withdrawn |
NCT00871065 -
Safety Study of Sildenafil in Treatment of Cerebral Aneurysm Vasospasm
|
Phase 2 | |
Recruiting |
NCT04691271 -
Stellate Ganglion Block and Cerebral Vasospasm
|
N/A | |
Recruiting |
NCT02432157 -
Safety and Feasibility of Hypertonic Saline Solution After Aneurysmal Subarachnoid Hemorrhage:
|
Phase 1/Phase 2 |