Patients with acute traumatic spinal cord injury are tested and documented within a fixed time schedule (acute, 4, 12, 24 and 48 weeks) after spinal cord injury and must comply with clearly defined inclusion criteria. The examinations consist of a standard set of neurological, neurophysiological and functional assessments. The collected data from each center is sent to the coordinating center (Zurich) in regulary time intervals to be joined into a central database.

A total of 19 paraplegic centers build up a close collaboration to discuss, plan and realize prospective studies within the scope of:

  • the relationship between electrophysiological, neurophysiological and functional measurements
  • the prognostic value of the measurement outcome
  • the mechanisms of spontaneous recovery
  • investigate the efficacy of new treatment strategies

Over 2300 patients (October 2011) with spinal cord injury are included in the EMSCI database. Several publications have emerged by the member hospitals of the project. Finally a network (EUCTN -European clinical trials network) has been founded to serve as contact for industrial clinical trials.

The success of our network can be measured by the undoubtedly high number of scientific publications and their corresponding noteworthy impact factor. Scientific publications demonstrate the quality of an academic network and EMSCI currently has the largest publishing record of all SCI networks in the world.

We will continously embed our network in the context of clinical interventions as a translational research tool.

 

ClinicalTrials.gov
EMSCI is on the registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. More...

 

ISO Certification for EMSCI
EMSCI has been ISO 9001:2008 certified since August 2010. More...

 

 


Aim:

Establishing a multi-center basis for future therapeutic interventions in human spinal cord injury.

 

The EMSCI assessment scheme currently consists of the so called core sets: neurological (ISNCSCI), functional (10MWT, 6MWT, TUG, WISCI2) measurements and independence measures (SCIM3). Additional assessments are: neurophysiology (MEP, SSEP, NCV), pain, hand function and an urodynamics.

In the clinical environment the problem arises that the acquisition of hundreds of parameters and the examination dates have to be coordinated in each participating center, which is a time and cost demanding challenge.

Therefore an electronic tool was developed within the EMSCI project. To fulfil the demands especially the concerns about data security, accessibility and flexibility we have decided not to implement a web-based concept, but to follow the standards of the “National Spinal Cord Injury Database”, which suggest a decentralized, stand-alone solution. The database is accessible via a network and is designed for simultaneous multi-user access. In regular intervals an updated version of the frontend is distributed. For performing the update no additional software tools are necessary. The unified implementation of the update database guarantees the flexibility needed within research projects.

The frontend contains all the definitions of the acquisition forms for the neurological, functional and electrophysiological documentation of SCI patients with a consistent appearance. Additional functions for automated time scheduling and a “missing tests”-function help to comply with the dedicated time frames for each patient. Either text-based or graphical reports may be generated. Beside rules for online data validation also additional calculation algorithms are included like an automated determination of the ASIA (American Spinal Injury Association) Impairment Scale. Especially the latter is an effective method for minimization of a likely source of errors in the formation of patient subgroups.

(from: Rupp R, et. al. An electronic tool for multicenter administration, assessment and analysis of clinical trials in spinal cord injury. Biomedizinische Technik, 2005)

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Main Patient Input Mask

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phase

exam stage

time frame

acute care

very acute

0 – 15 days

follow up

acute I

16 – 40 days

4 weeks

acute II

70 – 98 days

12 weeks

acute III

150 – 186 days

24 weeks

chronic

300 – 546 days

48 weeks

12 months