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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00011245 |
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 |
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Syringomyelia |
Study Type: | Observational |
Official Title: | Establishing the Pathophysiology of Primary Spinal Syringomyelia |
Estimated Enrollment: | 50 |
Study Start Date: | February 2001 |
Objective: The goal of this study is to establish the mechanism(s) of progression of primarily spinal syringomyelia (PSS), the type of syringomyelia that is associated with pathology in the spinal column and not at the craniocervical junction. Our hypothesis is that when a lesion obstructs the spinal subarachnoid space, it shortens the segment of spinal canal that dampens the CSF pressure waves that are produced with each heartbeat and creates enlarged spinal subarachnoid pressure waves that act on the spinal cord above the block to drive CSF into the spinal cord and create a syrinx. After a syrinx is formed, enlarged subarachnoid pressure waves compress the external surface of the spinal cord, propel the syrinx fluid, and promote syrinx progression.
Study Population: Subjects will have primary spinal syringomyelia associated with 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, or 4) an intramedullary tumor.
Design: Subjects will have testing before and after standard surgical therapy of syringomyelia. Testing includes measurement of CSF pressure, neurologic examination, CT-myelography, and MR scanning. Results of CSF pressure measurements before surgery will be compared to measurements from normal controls that were previously studied. The effect of surgery on CSF pressure, neurologic examination, CT-myelography, and MRI scans will be evaluated.
Outcome Measures: The primary outcome measure is cervical CSF pulse pressure, which is the amplitude of the CSF pressure wave, compared to normal values. Secondary outcomes measures include change in CSF pulse pressure, neurologic examination, CT-myelography, and MRI scans between before and after surgery.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
To be eligible to participate in this research study, the subject must :
Be 18 years of age or older.
Have syringomyelia or "presyringomyelia" (swelling of the spinal cord that precedes syringomyelia), documented by MRI.
Have evidence of neurological deterioration related to syringomyelia, "presyringomyelia", or spinal cord tumor. Prior surgery for syringomyelia does not result in exclusion from study.
Be able to comprehend the risks of testing and therapy and to give informed consent.
EXCLUSION CRITERIA:
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.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 010085, 01-N-0085 |
Study First Received: | February 14, 2001 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00011245 |
Health Authority: | United States: Federal Government |
Arachnoiditis Myelography Intraoperative Ultrasonography Magnetic Resonance CSF Pressure Trauma Meningitis Paralysis Spondylosis Spinal Syringomyelia |
Arachnoiditis Presyringomyelia Spinal Cord Edema Magnetic Resonance Imaging (MRI) Intraoperative Radiation Ultrasonography Trauma Spondylosis Meningitis Paralysis |
Paralysis Spinal Cord Diseases Syringomyelia Wounds and Injuries |
Central Nervous System Diseases Edema Arachnoiditis Meningitis |
Nervous System Diseases |