NCT00001327

Brief Summary

The brain and spinal cord are surrounded by fluid called cerebrospinal fluid (CSF). The CSF flows through channels in the brain and around the spinal cord. Occasionally, people are born with malformations of these channels. Syringomyelia is a pocket within the CSF channels that results from abnormal CSF flow. Syringomyelia is associated with problems in the nervous system. Patients with syringomyelia may be unable to detect sensations of pain and heat. If the condition is not treated it can worsen. Treatment of this condition is surgical. It requires that the flow of CSF is returns to normal. There are many different treatment options, but no one procedure has been shown to be significantly better than any other. In this study, researchers would like to learn more about how the CSF pressure and flow contribute to the progression of syringomyelia. Ultrasounds and magnetic resonance imaging (MRI) will be used to evaluate the anatomy of the brain. Researchers hope that information gathered about anatomy and measures of CSF pressure and flow can be used later to develop an optimal surgical treatment for syringomyelia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 1992

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 1992

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
11.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2011

Completed
Last Updated

July 2, 2017

Status Verified

March 31, 2011

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

SyringomyeliaChiari MalformationMagnetic Resonance ImagingIntraoperative UltrasonographyHydrocephalusSpinal CordVentriculostomyLumbar PuncturePressure Measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be eligible to participate in this research study, the subject must:
  • Be 18 years of age or older.
  • Have syringomyelia.
  • Be able to give informed consent.

You may not qualify if:

  • The subject will not be eligible to participate in this research study if the subject:
  • Is pregnant (because X-rays might injure a fetus).
  • Cannot have an MRI scan as determined by the radiologist.
  • Has a problem with bleeding that cannot be corrected.
  • Is unable to understand the risks of the testing and surgical therapy.
  • Has a blood test for HIV (the virus that causes AIDS) that is positive, because a positive HIV test would increase the risk of infection from research testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

  • Logue V, Edwards MR. Syringomyelia and its surgical treatment--an analysis of 75 patients. J Neurol Neurosurg Psychiatry. 1981 Apr;44(4):273-84. doi: 10.1136/jnnp.44.4.273.

    PMID: 7241155BACKGROUND
  • Oldfield EH, Muraszko K, Shawker TH, Patronas NJ. Pathophysiology of syringomyelia associated with Chiari I malformation of the cerebellar tonsils. Implications for diagnosis and treatment. J Neurosurg. 1994 Jan;80(1):3-15. doi: 10.3171/jns.1994.80.1.0003.

    PMID: 8271018BACKGROUND
  • Levy LM, Di Chiro G. MR phase imaging and cerebrospinal fluid flow in the head and spine. Neuroradiology. 1990;32(5):399-406. doi: 10.1007/BF00588473.

    PMID: 2259434BACKGROUND
  • Heiss JD, Suffredini G, Bakhtian KD, Sarntinoranont M, Oldfield EH. Normalization of hindbrain morphology after decompression of Chiari malformation Type I. J Neurosurg. 2012 Nov;117(5):942-6. doi: 10.3171/2012.8.JNS111476. Epub 2012 Sep 14.

MeSH Terms

Conditions

Arnold-Chiari MalformationHydrocephalusSyringomyelia

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBrain DiseasesCentral Nervous System DiseasesSpinal Cord Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 29, 1992

Study Completion

March 31, 2011

Last Updated

July 2, 2017

Record last verified: 2011-03-31

Locations