Trial document




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  DRKS00009757

Trial Description

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Title

Relationship between neuroimaging and clinical course after acute spinal cord injury

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This study aims to contribute for early insights for further development after an acute, accidental spinal cord injury with reference to a specific magnetic resonance imaging. These two studies established (ISNCSCI and neurophysiological measurements) are evaluated with the results of the special magnetic resonance imaging and mathematically correlated.
ISNCSCI stands for International Standards for Neurological Classification of Spinal Cord Injury and is an established test of the neurological status with respect to the remaining muscle function and sensitivity detected. The neurophysiological measurements include checking residual nerve fiber function.

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Brief Summary in Scientific Language

New MRI imaging and data processing procedures, which had not yet been established in the assessment of the spinal cord injury, are introduced as a future, expanded diagnostic procedures under the term of Neuro-Imaging. High-resolution MRI imaging of the spinal cord and its components can represent a major methodological advance in the clinical examination after acute traumatic spinal cord injury. Correlations of established clinical investigations like the ISNCSCI protocol, neurophysiological measurements (somatosensory potentials (SSEP), motor-evoked potentials (MEP), H-reflex and sympathetic skin response (SHR) and magnetic resonance imaging studies (MRI standard sequences, T2 * w and DTI will be examined, the correlations ). Due to the EMSCI-time scheme (European Multicenter Study about Spinal Cord Injury), the valence of Neuro-Imaging with respect to an assessment of the course and prognosis should be estimated. In particular for patients with impaired vigilance and clinical assessability it could be a possibility to create diagnosis by MRI at an early stage and could supply an individually adapted therapy.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009757
  •   2015/12/23
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  •   yes
  •   Approved
  •   15116, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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Health Condition or Problem studied

  •   S14 -  Injury of nerves and spinal cord at neck level
  •   S24 -  Injury of nerves and spinal cord at thorax level
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Interventions/Observational Groups

  •   In four defined periods after spinal cord injury 3 diagnostic assessments are put to use at any participating patient:
    ISNCSCI
    Neurophysiological measurements (SSEP, MEP, SHR)
    MRI with DTI sequences
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Correlation between DTI Parameters (FA, ADC Correlat) an the shifting of ISNCSCI protocol sensory scores (LT, PP) at the time points very acute (day 1-15), acute I (day 16-40), acute II (day 70-98) and chronic (day 300-400).

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Secondary Outcome

Correlation between DTI parameters (FA, ADC correlate) and the changes in the protocol with ISNCSCI Total Motor Score, Upper Extremities Motor Score (UEMS), Lower Extremities Motor Score (LEMS), and ASIA Impairment Scale (AIS) at the time points very acute (day 1-15), acute I (day 16-40), acute II (day 70-98) and chronic (day 300-400).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/01/14
  •   51
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Acute paraplegia preoperatively with existing spinal lesion traumatic genesis in the level C5 to Th12. From May 1st 2017 acute paraplegia preoperatively with existing spinal lesion traumatic genesis in the level C5 to C8.

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Exclusion Criteria

Age under 18 and over 75 years
Heavy head injury
Multilocular spinal lesions
Cauda equina syndrome
plexus lesion
Peripheral nerve lesion
Pacemaker
Pacemaker leads
Instrumentations with disturbing artifacts generating Cages (eg tantalum)

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Addresses

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    • BG Klinikum Murnau
    • Professor-Küntscher-Str. 8
    • 82418  Murnau am Staffelsee
    • Germany
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    • BG Klinikum Murnau
    • Mr.  Dr. med.  Florian  Högel 
    • Prof.-Küntscher-Str. 8
    • 82418  Murnau am Staffelsee
    • Germany
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    • BG Klinikum Murnau
    • Mr.  Orpheus  Mach 
    • Prof.-Küntscher-Str. 8
    • 82418  Murnau am Staffelsee
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Gesetzliche Unfallversicherung (DGUV)Stabsbereich Prävention Forschungsförderung
    • Mr.  Dr.  Michael  Schmidt 
    • Alte Heerstr. 111
    • 53754  Sankt Augustin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.