Trial document
DRKS00015842
Trial Description
Title
Maximum Bite Force in Patients with Spinal Muscular Atrophy during the First Year of Nusinersen Therapy
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.
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.
Do you plan to share individual participant data with other researchers?
Yes
Description IPD sharing plan:
Only in the context of scientific publications (e.g. study protocol).
Organizational Data
- DRKS00015842
- 2019/07/30
- [---]*
- yes
- Approved
- 19-1137_1, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
Secondary IDs
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Health Condition or Problem studied
- G12.1 - Other inherited spinal muscular atrophy
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.
Characteristics
- Non-interventional
- Observational study
- Non-randomized controlled trial
- Open (masking not used)
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- Control group receives no treatment
- Other
- Other
- N/A
- N/A
Primary Outcome
Relative changes in maximum bite force. Measured with piezoelectric transducers. Maximum bite force is repeatedly measured over the course of one year.
Secondary Outcome
Relative change of maximum bite force.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- University Medical Center
Recruitment
- Actual
- 2020/07/24
- 50
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 50 Years
Additional Inclusion Criteria
Patients with spinal muscular atrophy type I or II.
Exclusion Criteria
SMA type III
Addresses
-
start of 1:1-Block address primary-sponsor
- Poliklinik für Kieferothopädie, Uniklinik Köln
- Kerpener Str. 32
- 50931 Köln
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
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end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- Poliklinik für Neurologie
- Mr. Dr. Gilbert Wunderlich
- Kerpener Str. 62
- 50937 Köln
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- [---]*
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end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Poliklinik für Kieferorthopädie, Uniklinik Köln
- Ms. Dr. Teresa Kruse
- Kerpener Str. 32
- 50931 Köln
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0049 221 478 4712
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- teresa.kruse at uk-koeln.de
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end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Poliklinik für Kieferorthopädie, Uniklinik Köln
- Ms. Dr. Teresa Kruse
- Kerpener Str. 32
- 50931 Köln
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0049 221 478 4712
- [---]*
- teresa.kruse at uk-koeln.de
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Poliklinik für Kieferorthopädie, Uniklinik Köln
- Ms. Dr. Teresa Kruse
- Kerpener Str. 32
- 50931 Köln
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- 0049 221 478 4712
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- teresa.kruse at uk-koeln.de
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end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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