Trial document



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  DRKS00015842

Trial Description

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Title

Maximum Bite Force in Patients with Spinal Muscular Atrophy during the First Year of Nusinersen Therapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

We measure bite force in patients with spinal muscular atrophy. These patients receive a therapy with nusinersen. We hope to evaluate the effect of the therapy on the bulbar function based on the bite force measurements.

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Brief Summary in Scientific Language

Spinal muscular atrophy (SMA) is characterized by progressive spinal and bulbar muscle weakness and atrophy caused by the degeneration of alpha-motoneurons. The recent approval of the antisense oligonucleotide nusinersen highlights the need for reliable clinical tools to evaluate motor function in patients with SMA. This study’s aim is to test if maximum bite force measurement is suitable to quantify changes of altered bulbar function during nusinersen therapy.
We want to include patients at an advanced state of SMA. In patients in an advanced stage, the maximum bite force could be a quantitative measure of the bulbar function and thus an alternative to conventional motor scales, which require residual mobility of the extremities and of the head. The aim of this study is to perform isometric bite force measurements in SMA patients to show possible changes in maximum bite force indicating changes in bulbar function. A piezoelectric force sensor registers the maximum bite force in the posterior region recorded by the CEBO-MSA64 software. Relative bite force changes in different treatment phases are analyzed.

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

Yes

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Description IPD sharing plan:

Only in the context of scientific publications (e.g. study protocol).

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Organizational Data

  •   DRKS00015842
  •   2019/07/30
  •   [---]*
  •   yes
  •   Approved
  •   19-1137_1, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   G12.1 -  Other inherited spinal muscular atrophy
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Interventions/Observational Groups

  •   We measure bite force in patients with spinal muscular atrophy during Nusinersen therapy (Spinraza, Biogen).
  •   We measure bite force in patients with spinal muscular atrophy before and during Nusinersen therapy (Spinraza, Biogen).
  •   We measure bite force in patients with spinal muscular atrophy without Nusinersen therapy.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Relative changes in maximum bite force. Measured with piezoelectric transducers. Maximum bite force is repeatedly measured over the course of one year.

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Secondary Outcome

Relative change of maximum bite force.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/07/24
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patients with spinal muscular atrophy type I or II.

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Exclusion Criteria

SMA type III

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Addresses

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    • Poliklinik für Kieferothopädie, Uniklinik Köln
    • Kerpener Str. 32
    • 50931  Köln
    • Germany
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    • Poliklinik für Neurologie
    • Mr.  Dr.  Gilbert  Wunderlich 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    •   [---]*
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    • Poliklinik für Kieferorthopädie, Uniklinik Köln
    • Ms.  Dr.  Teresa  Kruse 
    • Kerpener Str. 32
    • 50931  Köln
    • Germany
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    • Poliklinik für Kieferorthopädie, Uniklinik Köln
    • Ms.  Dr.  Teresa  Kruse 
    • Kerpener Str. 32
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Poliklinik für Kieferorthopädie, Uniklinik Köln
    • Ms.  Dr.  Teresa  Kruse 
    • Kerpener Str. 32
    • 50931  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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