Status:
ACTIVE_NOT_RECRUITING
A Prospective Natural History Study of Patients With Syringomyelia
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Syringomyelia
Arnold Chiari Deformity
Eligibility:
All Genders
18+ years
Brief Summary
Background: * Syringomyelia is a disorder in which a cyst (syrinx) forms within the spinal cord and causes spinal cord injury, with symptoms worsening over many years, including paralysis, loss of se...
Detailed Description
OBJECTIVE The natural history of patients who have syringomyelia has not been addressed in a prospective study. Present surgical treatment of patients with syringomyelia and neurologic deficit result...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be eligible to participate in this research study, the subject must:
- Be 18 years of age or older.
- Have syringomyelia, presyringomyelia, or Chiari I malformation without syringomyelia.
- Be able to give informed consent.
- ADDITIONAL CRITERIA FOR PATIENTS THAT MAY UNDERGO SURGERY (not required for study inclusion)
- new or increased impairment in sensation, strength, or walking within the previous 2 years; and
- an MRI-scan showing a syrinx or the presence of abnormal fluid and swelling in the spinal cord; the abnormality in the spinal cord must be located in a part of the spinal cord that could produce the patient s symptoms; and
- evidence of abnormalities at the base of the skull or within the spine that are often associated with syringomyelia, or abnormalities in CSF circulation that increase the pressure of the cerebrospinal fluid; and
- medical health that is sufficient to allow the subject to withstand a major surgical procedure and to remain active during the recovery period after surgery.
- EXCLUSION CRITERIA:
- The subject will not be eligible to participate in this research study if the subject:
- Is pregnant (because multiple MRI scans might injure a fetus).
- Cannot have an MRI scan as determined by the radiologist (see the risks below).
- Has a problem with bleeding that cannot be corrected.
- Note: Prior surgery for syringomyelia does not result in exclusion from the study if there is radiographic evidence of recurrent or persistent syringomyelia after surgery for this condition (failed previous surgery).
Exclusion
Key Trial Info
Start Date :
August 3 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT01150708
Start Date
August 3 2010
Last Update
December 26 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892