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NCT00011245 · ClinicalTrials.gov registry record

Study and Surgical Treatment of Syringomyelia

A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
50
Enrollment target

NCT00011245: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NCT00011245 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00011245 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
50 participants
Enrollment target

Study 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 protoco

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2001-02-08
Est. Completion 2011-05-18

What the finished NCT00011245 record still lists

NCT00011245 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00011245 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00011245 about?

NCT00011245 is a clinical study titled "Study and Surgical Treatment of Syringomyelia". 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 exp...

What is the current status of trial NCT00011245?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2001-02-08. Estimated completion is 2011-05-18.

Who is sponsoring clinical trial NCT00011245?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00011245, the US trial registry maintained by the National Library of Medicine. NCT00011245 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.