Trial document




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  DRKS00012962

Trial Description

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Title

Cervical spondylotic myelopathy: Application of spinal diffusion-based microstructural imaging (DMI) and phase-contrast MRI

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Trial Acronym

MIDICAM

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URL of the Trial

http://keine

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Brief Summary in Lay Language

[---]*

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Brief Summary in Scientific Language

The diagnosis and resulting treatment recommendation in patients with cervical spondylotic myelopathy based on the current established diagnostics clinical examination, electrophysiology and conventional MRI sequences is often challenging because of the limited matching of the diagnostic parameters in some patients. The problem appears especially in early stages of the disease with abstinent or mild symptoms or unspecific conditions based on comorbidities. Because of the high risk for persistent neurological disorders in delayed treatment, an early detection of affected patient with an ubiquitary applicable imaging would be favourable. Conventional MRI in cervical myelopathy with T1- and T2-sequences shows only limited matching with the clinical symptoms in at best 60%.

The Microstructural Diffusion Imaging (MIDI) is a innovative imaging for microstructural disturbances on a subvoxel compartment model of the diffusion tensor imaging. Diffusion restricted areas can be depicted more sensitive than in conventional diffusion imaging. This could be shown in patients with cerebral ischemia. Therefore we have the hypothesis that cervical diffusion-restricted areas in spondylitic myelopathy can be seen more sensitive too and the correlation with clinical impairment and electrophysiological findings can be optimised.

This question will be addressed in this study with a prospective evaluation of patients with monosegmantal cervical disc herniation or spinal stenosis and possible myelopathy with this new MIDI modality. A clinical re-evaluation will be done three, six and twelve month after inclusion examination. Therapy decision should be unaffected, but we will observe the clinical course and another MRI and electrophysiogical examination after 12 month. The sensitivity and specifity of the new imaging modality will be calculated and the association with clicical, electrophyiological and concventional imaging findings evaluated. Thus objective of our study is to optimise the diagnosis of cervical myelopathy and associated the patient information concerning the prognosis of their disease.

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Organizational Data

  •   DRKS00012962
  •   2018/01/17
  •   [---]*
  •   yes
  •   Approved
  •   261/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M47.12 -  [generalization M47.1: Other spondylosis with myelopathy]
  •   G99.2 -  Myelopathy in diseases classified elsewhere
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Interventions/Observational Groups

  •   In this propective study we will apply additional new MRI examinations (MDI/PC-MRI) in patients with cervical spondylotic pathologies and possible associated myelopathy to figure out their diagnostic and prognostic value.
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Characteristics

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

Sensitivity and specifity of the MIDI concerning functional (clinical or electrophysiological) or abstinent myelopathy.

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Secondary Outcome

Pathologic changings in the MIDI compared to conventional MRI diagnostics in cervical myelopathy patients. Development of clinical, electrophysiological and conventional MRI changings in initial pathological altered MIDI.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/04/01
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

a) Symptoms of a radiculopathy od myelopthy induced by cervical degerative disease in combination with a disk herniation or cervical stenosis with contact to the cervical myelon at the MR imaging. b) Age > 18 years c) Informed consent.

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Exclusion Criteria

a) MRI exclusion criteria b) Patients with prior cervical operations c) Non-degenerative causes for the pathological changings of the cervical spine (tumor, infection/inflammation, tramatic injuries) d) severe internistic pathologies e) severe neurologic or psychiatric diseases, e.g. dementia, Parkinson's disease, Multiple sclerosis, CNS inflammation, Depression, Schizophrenia

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Addresses

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    • Klinik für Neurochirurgie, Universitätsklinikum Freiburg
    • Mr.  Dr.  Marc  Hohenhaus 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Klinik für Neurochirurgie, Universitätsklinikum Freiburg
    • Mr.  Dr.  Marc  Hohenhaus 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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    • Klinik für Neurochirurgie, Universitätsklinikum Freiburg
    • Mr.  Dr.  Marc  Hohenhaus 
    • Breisacher Str. 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Neurochirurgie, Universitätsklinikum Freiburg
    • Mr.  Dr.  Marc  Hohenhaus 
    • Breisacher Str. 64
    • 79106  Freiburg
    • 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.