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  Personalized neurorehabilitative precision medicine: from data to therapies (MWKNeuroReha) - a multi-centre prospective observational clinical trial to predict long-term outcome of patients with acute motor stroke

Blum, C., Baur, D., Achauer, L.-C., Berens, P., Biergans, S., Erb, M., et al. (2022). Personalized neurorehabilitative precision medicine: from data to therapies (MWKNeuroReha) - a multi-centre prospective observational clinical trial to predict long-term outcome of patients with acute motor stroke. BMC Neurology, 22(1): 238. doi:10.1186/s12883-022-02759-2.

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 Creators:
Blum, C, Author
Baur, D, Author
Achauer, L-C, Author
Berens, P, Author              
Biergans, S, Author
Erb, M1, Author              
Hömberg, V, Author
Huang, Z, Author
Kohlbacher, O, Author              
Liepert, J, Author
Lindig, T, Author              
Lohmann, G1, Author              
Macke, JH, Author              
Römhild, J, Author
Rösinger-Hein, C, Author
Zrenner, B, Author
Ziemann, U, Author
Affiliations:
1Department High-Field Magnetic Resonance, Max Planck Institute for Biological Cybernetics, Max Planck Society, ou_1497796              

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 Abstract: Background: Stroke is one of the most frequent diseases, and half of the stroke survivors are left with permanent impairment. Prediction of individual outcome is still difficult. Many but not all patients with stroke improve by approximately 1.7 times the initial impairment, that has been termed proportional recovery rule. The present study aims at identifying factors predicting motor outcome after stroke more accurately than before, and observe associations of rehabilitation treatment with outcome. Methods: The study is designed as a multi-centre prospective clinical observational trial. An extensive primary data set of clinical, neuroimaging, electrophysiological, and laboratory data will be collected within 96 h of stroke onset from patients with relevant upper extremity deficit, as indexed by a Fugl-Meyer-Upper Extremity (FM-UE) score ≤ 50. At least 200 patients will be recruited. Clinical scores will include the FM-UE score (range 0-66, unimpaired function is indicated by a score of 66), Action Research Arm Test, modified Rankin Scale, Barthel Index and Stroke-Specific Quality of Life Scale. Follow-up clinical scores and applied types and amount of rehabilitation treatment will be documented in the rehabilitation hospitals. Final follow-up clinical scoring will be performed 90 days after the stroke event. The primary endpoint is the change in FM-UE defined as 90 days FM-UE minus initial FM-UE, divided by initial FM-UE impairment. Changes in the other clinical scores serve as secondary endpoints. Machine learning methods will be employed to analyze the data and predict primary and secondary endpoints based on the primary data set and the different rehabilitation treatments. Discussion: If successful, outcome and relation to rehabilitation treatment in patients with acute motor stroke will be predictable more reliably than currently possible, leading to personalized neurorehabilitation. An important regulatory aspect of this trial is the first-time implementation of systematic patient data transfer between emergency and rehabilitation hospitals, which are divided institutions in Germany.

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 Dates: 2022-06
 Publication Status: Published online
 Pages: -
 Publishing info: -
 Table of Contents: -
 Rev. Type: -
 Identifiers: DOI: 10.1186/s12883-022-02759-2
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Title: BMC Neurology
Source Genre: Journal
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Publ. Info: BioMed Central
Pages: 15 Volume / Issue: 22 (1) Sequence Number: 238 Start / End Page: - Identifier: ISSN: 1471-2377
CoNE: https://pure.mpg.de/cone/journals/resource/111032787578006