Trial document




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  DRKS00008584

Trial Description

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Title

Molecular and histopathological examinations of adhesions in patients with posttraumatic syringomyelia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Up to 30% of all patients with traumatic spinal cord injuries develop a syrinx formation within the spinal cord months to years after the initial trauma. This may lead to ascending neurologic impairment as well as increased pain and spasticity. Subarachnoidal scarring leading to altered CSF flow plays most likely a significant role in the pathophysiology. Adhesiolysis of these arachnoid scarring may result in improvement. The molecular mechanism of the scarring and the involved cells are largely unknown.

With this study we try to evaluate the role of TGF-beta (transforming growth factor beta) and its downstream pathway in patients with post traumatic syringomyelia. This protein plays an essential role in diverse wound healing as well as scarring processes within the human body.

We will further study TGF-beta concentrations in the serum and CSF.
Arachnoid tissue from patients with intrapinal pathologies other than posttraumatic syringomyelia will serve as a control group.

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Brief Summary in Scientific Language

Up to 30% patients with spinal cord injury develop a syringomyelia - characterized with a central enlargement within the spinal cord - several months to years after the initial trauma [1].
Clinical sequels are ascending neurologic impairment, autonomic dysfunction and increased spasticity. Not all patients show these symptoms, as slow progression of the central cyst is sometimes observed[2].
There are several theories regarding syrinx development - reflecting the complexity of this disorder. After the initial trauma to the spinal cord, a secondary cascade (ischemia, excitotoxicity, edema and scarring). The scarring takes also place in the subarachnoid space and may lead to altered circulation of cerebrospinal fluid flow and pressure dynamic differences. This can result in increased flow towards the center of the spinal cord.
Specific mechanism for the development of a post traumatic syringomyelia a largely unknown. There is limited clinical and scientific expertise with this pathology. Treatment options are scarce. Surgical intervention is sometimes necessary, in case of rapid ascending neurologic deficits. The removal of epidural scarring, adhesiolysis and in some centers shunting of the cavity are potential surgical options. However subarachnoid scarring reoccurs relative frequently leading to further decline [4].
Desired treatment options would be preventions of syrinx formation as well as subarachnoid scarring. To achieve this goal, a better understanding of molecular and histopathological mechanisms is necessary.


Literature:
1. Backe, H.A., et al., Post-traumatic spinal cord cysts evaluated by magnetic resonance imaging. Paraplegia, 1991. 29(9): p. 607-12.
2. Brodbelt, A.R. and M.A. Stoodley, Post-traumatic syringomyelia: a review. J Clin Neurosci, 2003. 10(4): p. 401-8.
3. Fehlings, M.G. and J.W. Austin, Posttraumatic syringomyelia. J Neurosurg Spine, 2011. 14(5): p. 570-2; discussion 572.
4. Holly, L.T., et al., Treatment of posttraumatic syringomyelia with extradural decompressive surgery. Neurosurg Focus, 2000. 8(3): p. E8.



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Organizational Data

  •   DRKS00008584
  •   2015/08/21
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  •   no
  •   Approved
  •   15043, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  •   U1111-1173-4120 
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Health Condition or Problem studied

  •   G95.0 -  Syringomyelia and syringobulbia
  •   G82 -  Paraplegia and tetraplegia
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Interventions/Observational Groups

  •   Spinal cord injured patient, who require adhesiolysis due to rapid ascending neurologic deficits (analysis of subarachnoid scarring tissue, serum and CSF)
  •   Control group (patients who require medullary surgery other than adhesiolysis for syringomyelia) (analysis of subarachnoid septae, serum and CSF)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Displaying histopathological hallmarks of syringomyelia (TGF-beta and pathway mediators in histology, CSF and serum)

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Secondary Outcome

identification of other molecular risk factor for posttraumatic syringomyelia (in Serum or CSF, or other than TGF-ß).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2015/09/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- prior spinal cord injury
- development of posttraumatic syringomyelia

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Exclusion Criteria

- Syringomyelia related to other causes (Arnold Chiari, postinfectious etc.)
- absent informed consent

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Addresses

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    • BG Trauma Center Murnau
    • Mr.  Dr. med. univ.  Lukas  Grassner 
    • 82418  Murnau
    • Germany
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    • Zentrum für Rückenmarkverletzte / Abteilung für Neurochirurgie
    • Mr.  Dr. med. univ.  Lukas  Grassner 
    • Prof. Küntscher Str. 8
    • 82418  Murnau
    • Germany
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    • Center for Spinal Cord Injuries, BG Trauma Center Murnau, Germany
    • Mr.  Dr. med. univ.  Lukas  Grassner 
    • Prof. Küntscher Str. 8
    • 82418  Murnau
    • Germany
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Sources of Monetary or Material Support

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    • BG Trauma Center Murnau
    • 82418  Murnau
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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