NISCI

Antibodies against Nogo-A to enhance regeneration and functional recovery after acute spinal cord injury, a multicenter European clinical proof of concept trial

This project aims to apply a novel qMRI protocol covering brain and cervical cord down to C4 level as a sub-study within the clinical trial NISCI (www.nisci-2020.eu) to identify iron and myelin-changes in the spinal cord and brain and correlate them to the level of deficit and functional improvement of the patients in the two treatment groups (ATI355 vs. placebo).

 

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Biomarkers for the NISCI trial

 

The NISCI clinical trial is a state-of-the-art placebo-controlled multicentric phase II clinical trial in a consortium of seven leading European SCI centers to assess the efficacy of anti-Nogo-A antibody therapy to significantly improve the neurological recovery and functional outcome of spinal cord injured patients.

The multi-parameter mapping has been optimized for the application on clinical 3T scanners based on product sequences (1 mm isotropic resolution, scanning time <25 min) (Leutritz et al., 2020, HBM). To evaluate the protocol setup for consistency between and within sites (test-retest) we performed a traveling heads study with five healthy subjects across six sites, involving different scanner hard- and software with five healthy subjects across six sites, involving different scanner hard- and software (Leutritz et al., 2020, HBM, 41:42 32– 4247).

For processing the data we used the hMRI-toolbox (www.hmri.info) for quantitative MRI data, which is developed by the MPI-CBS and an international consortium (Tabelow et al., 2019, NeuroImage, 194, 191-210). This study is supported by Horizon 2020 Framework Programme, 681094.