Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011245
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2001-02-14
Brief Title:
Study and Surgical Treatment of Syringomyelia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Establishing the Pathophysiology of Primary Spinal Syringomyelia
Status:
COMPLETED
Status Verified Date:
2011-05-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to establish the mechanisms 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
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
Detailed Description:
Objective The goal of this study is to establish the mechanisms 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-N-0085 | None | None | None |