Cervical Spinal Cord Stimulation in Cerebral Vasospasm

NCT02426827 | Withdrawn

• 1 other identifier: 14-007493
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Vasospasm

Outcome Measures

Primary Outcomes (1)

• Looking at number of patients without an adverse effect

  7 days

Study Arms (1)

SCS in CV

EXPERIMENTAL

Device: Spinal Cord Stimulation

Interventions

Spinal Cord Stimulation DEVICE

SCS in CV

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Related Publications (10)

• 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.

  PMID: 19409714 BACKGROUND

• 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.

  PMID: 17995571 BACKGROUND

• 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.

  PMID: 3879799 BACKGROUND

• 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.

  PMID: 1705326 BACKGROUND

• 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.

  PMID: 10927901 BACKGROUND

• 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.

  PMID: 18500217 BACKGROUND

• 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.

  PMID: 20648204 BACKGROUND

• 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.

  PMID: 15109517 BACKGROUND

• 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.

  PMID: 21345703 BACKGROUND

• 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.

  PMID: 11588316 BACKGROUND

MeSH Terms

Conditions

Vasospasm, Intracranial

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Scott C Palmer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: July 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 22, 2018

Record last verified: 2018-03