http://clinicaltrials.gov/ct/gui/c/a1b/show/NCT00011245?order=7&JServSessionId zone_ct=zhn5b9gan1

Study and Surgical Treatment of Syringomyelia

This study is currently recruiting patients.

Sponsored by

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

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.

Condition
Syringomyelia


MEDLINEplusrelated topics:SpinalCordDiseases

Study Type:Natural History


Official Title:Establishing the Pathophysiology of Primary Spinal Syringomyelia

Further Study Details:

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.

Eligibility

Genders Eligible for Study: Both

Criteria

18 years of age or older
Must have syringomyelia or "presyringomyelia" (swelling of the spinal cord that precedes syringomyelia), documented by MRI. Must have evidence of neurological deterioration related to syringomyelia, "presyringomyelia", or spinal cord tumor. Prior surgery for syringomyelia does not result in exclusion from study. Must be able to comprehend the risks of testing and therapy and to give informed consent. Must not be pregnant.
Must be able to have an MRI scan as determined by a radiologist. Must not have a problem with bleeding that cannot be corrected. Must be able to understand the risks of the testing and surgical therapy. Blood test for HIV (the virus that causes AIDS) must not be positive, unless an infectious disease consultant determines by further testing of your immune system that a positive HIV test would not increase your risk of infection.


Location and Contact Information

Maryland
National Institute of Neurological Disorders and Stroke (NINDS),9000 Rockville Pike Bethesda, Maryland, 20892, United States;Recruiting

PRPL 1-800-411-1222 prpl@mail.cc.nih.gov

More Information

Detailed Web Page

Publications

Heiss. 1999. Elucidating the pathophysiology of syringomyelia, J Neurosurg, Vol. 91, p. 553

Levy. 2000. Spinal cord swelling preceding syrinx development: case report, J Neurosurg, Vol. 92, p. 93

Oldfield. 1994. Pathophysiology of syringomyelia associated with Chiari I malformation of the cerebellar tonsils Implications for diagnosis and treatment, J Neurosurg, Vol. 80, p. 3

Study ID Numbers 01-N-0085
NLM Identifier NCT00011245

Date study startedFebruary 8, 2001
Record last reviewed January 29, 2001
Last Updated January 29, 2001

[This message was edited by Wise Young on August 06, 2001 at 12:38 PM.]