NCT00011245

Brief Summary

The goal of this study is to establish the mechanism(s) of progression of primarily spinal syringomyelia (PSS). Our preliminary study of syringomyelia emphasized syringomyelia associated with craniocervical junction abnormalities (CCJAS), such as the Chiari I malformation. This new protocol will expand the scope of our investigation to include primarily spinal syringomyelia (PSS), which is defined as syringomyelia not associated with craniocervical junction abnormalities (CCJAS). Etiologies of primarily spinal syringomyelia include 1) intradural scarring which is post-traumatic, post-inflammatory, or post-operative, 2) intradural-extramedullary masses such as arachnoid cysts or meningiomas, and 3) extramedullary-extradural spinal lesions such as cervical spondylosis or spinal deformity. Our hypothesis is the following: Primarily spinal syringomyelia (PSS), results from obstruction of cerebrospinal fluid (CSF) flow within the spinal subarachnoid space; this obstruction affects spinal CSF dynamics because the spinal subarachnoid space accepts the fluid that is displaced from the intracranial subarachnoid space as the brain expands during cardiac systole; in the case of primarily spinal syringomyelia (PSS), a subarachnoid block effectively shortens the spinal subarachnoid space, reducing CSF compliance and the capacity of the spinal theca to dampen the subarachnoid CSF pressure waves produced by the brain expansion during cardiac systole; the exaggerated spinal subarachnoid pressure waves occur with every heartbeat and act on the spinal cord above the block to drive CSF into the spinal cord and create a syrinx. Presyringomyelia, a recently described state of spinal cord edema associated with progressive myelopathy and obstruction in CSF flow, is a precursor stage to syringomyelia that is consistent with this hypothesis. Because of the importance of this condition to the pathophysiology of syringomyelia, we will also study patients with presyringomyelia in this protocol. After a syrinx is formed, the enlarged subarachnoid pressure waves compress the external surface of the spinal cord, propel the syrinx fluid, and promote syrinx progression. Many neurosurgeons at prominent academic centers routinely use syrinx shunts to treat primarily spinal syringomyelia. This study should provide data that a surgical procedure that opens the spinal subarachnoid space corrects the underlying pathophysiology and resolves the syrinx and that invasion of the spinal cord is unnecessary.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2001

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2001

Completed
10.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2011

Completed
Last Updated

July 2, 2017

Status Verified

May 18, 2011

First QC Date

February 14, 2001

Last Update Submit

June 30, 2017

Conditions

Keywords

ArachnoiditisMyelographyIntraoperative UltrasonographyMagnetic ResonanceCSF PressureTraumaMeningitisParalysisSpondylosisSpinal SyringomyeliaPresyringomyeliaSpinal Cord EdemaMagnetic Resonance Imaging (MRI)Intraoperative RadiationUltrasonography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible to participate in this research study, the subject must:
  • Be 18 years of age or older.
  • Have syringomyelia documented by MRI.
  • Be able to comprehend the risks of testing and therapy and to give informed consent.

You may not qualify if:

  • Subjects will not eligible to participate in this research study if:
  • They are pregnant (because X-rays might injure a fetus).
  • They cannot have an MRI scan as determined by a radiologist.
  • They have a problem with bleeding that cannot be corrected.
  • They are unable to understand the risks of the testing and surgical therapy.
  • Their blood test for HIV (the virus that causes AIDS) is positive, because a positive HIV test would increase your risk of infection from research testing.
  • They have syringomyelia which developed after meningitis, because we have found that laminectomy and duroplasty is ineffective in this setting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

  • Heiss JD, Patronas N, DeVroom HL, Shawker T, Ennis R, Kammerer W, Eidsath A, Talbot T, Morris J, Eskioglu E, Oldfield EH. Elucidating the pathophysiology of syringomyelia. J Neurosurg. 1999 Oct;91(4):553-62. doi: 10.3171/jns.1999.91.4.0553.

    PMID: 10507374BACKGROUND
  • Levy EI, Heiss JD, Kent MS, Riedel CJ, Oldfield EH. Spinal cord swelling preceding syrinx development. Case report. J Neurosurg. 2000 Jan;92(1 Suppl):93-7. doi: 10.3171/spi.2000.92.1.0093.

    PMID: 10616064BACKGROUND
  • Oldfield EH, Muraszko K, Shawker TH, Patronas NJ. Pathophysiology of syringomyelia associated with Chiari I malformation of the cerebellar tonsils. Implications for diagnosis and treatment. J Neurosurg. 1994 Jan;80(1):3-15. doi: 10.3171/jns.1994.80.1.0003.

    PMID: 8271018BACKGROUND
  • Heiss JD, Snyder K, Peterson MM, Patronas NJ, Butman JA, Smith RK, Devroom HL, Sansur CA, Eskioglu E, Kammerer WA, Oldfield EH. Pathophysiology of primary spinal syringomyelia. J Neurosurg Spine. 2012 Nov;17(5):367-80. doi: 10.3171/2012.8.SPINE111059. Epub 2012 Sep 7.

MeSH Terms

Conditions

SyringomyeliaArachnoiditisWounds and InjuriesMeningitisParalysisSpondylosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

February 14, 2001

First Posted

February 15, 2001

Study Start

February 8, 2001

Study Completion

May 18, 2011

Last Updated

July 2, 2017

Record last verified: 2011-05-18

Locations