Outcome measures

ENCALS centres connected to the European trial network TRICALS have agreed on the protocols for outcome measures in clinical trials. These were discussed in the TRICALS workshop on 21 and 22 of May 2016 in Milan. If you would like further information or if you have or need a translation of an SOP or questionnaire, please contact info@encals.eu

ALS core clinical dataset

A standard core clinical dataset has been defined with input from ALS researchers internationally. Read more or join international collaborative projects.

E-modules for training

For ALS-FRS-R, respiratory measurement and muscle strength, e-learning modules are available for all who are working at an ALS centre connected to TRICALS. If you would like to request access to these, please email info@tricals.org.

ALS-FRS-R

Respiratory measurement

The SOP for respiratory measurement has been discussed in the TRICALS workshop in May 2016 and will be further improved over the coming year. If you have any comments, please email info@encals.eu

Isometric Strength Testing

ECAS

ECAS stands for Edinburgh Cognitive and Behavioural ALS Screen. ECAS is a brief, 15–20 minute, assessment of a range of cognitive and behavioural changes, designed specifically for people with MND. It makes cognitive assessment faster and more accessible as it can be used in the clinic or a patient’s home.

Please visit the ECAS website for the ECAS, the ECAS guidelines and training material.

For German and Swiss ALS centres a German guideline for ECAS, as well as the German and soon Swiss German Version of the ECAS are available.

Staging

Reference: Balendra R, Jones A, Jivraj N, Steen IN, Young CA, Shaw PJ, Turner MR, Leigh PN, Al-Chalabi A; UK-MND LiCALS Study Group, Mito Target ALS Study Group. Use of clinical staging in amyotrophic lateral sclerosis for phase 3 clinical trials. J Neurol Neurosurg Psychiatry. 2015;86(1):45-9. doi: 10.1136/jnnp-2013-306865.

MUNIX

Several courses have been successfully held in St.Gallen and during ENCALS meetings. MUNIX has become a standard outcome measure within Europe to follow demise of motor neurons in ALS patients. Its greatest advantage is that MUNIX can be performed  on proximal and distal muscles within a short amount of time allowing to  get a “body scan” of surviving motor units.  Longitudinal MUNIX measurements are part of the European SOPHIA project and are expected to be soon applied in clinical trials. For further information contact christoph.neuwirth@kssg.ch

MUNIX Protocol_v1.0_Dec2017

References:

  • Neuwirth C, Nandedkar S, Stålberg E, Barkhaus PE, Carvalho Md, Furtula J, van Dijk JP, Baldinger R, Castro J, Costa J, Otto M, Sandberg A, Weber M. Motor Unit Number Index (MUNIX): reference values of five different muscles in healthy subjects from a multi-centre study. Clin Neurophysiol. 2011 Sep;122(9):1895-8
  • Neuwirth C, Nandedkar S, Stålberg E, Barkhaus PE, Carvalho Md, Furtula J, Dijk JP, Baldinger R, Castro J, Costa J, Otto M, Sandberg A, Weber M. Motor Unit Number Index (MUNIX): a novel neurophysiological marker for neuromuscular disorders; test-retest reliability in healthy volunteers. Clin Neurophysiol. 2011 Sep;122(9):1867-72