Innovations in ALS clinical trials through the TRICALS Academy

Last month marked a significant moment for the TRICALS Academy, as the first live training of the newly developed ‘electrophysiological assessments’ course took place. ALS professionals from all over the world gathered in the UMC Utrecht, to learn the ins and outs of assessing motor functioning. 

Boudewijn Sleutjes (biomedical engineer, PhD), one of the initiators of the course, talks about the innovations this course brings to the TRICALS Academy and ALS research. Sleutjes: “We are really proud to bring this technique into clinical research practice.” 

Electrophysiological assessments 

Electrophysiological assessments using conventional techniques are already in use in the clinic to diagnose ALS. “In the past years there have been many technical and methodological developments in the field of electrophysiological assessments, making the technique more suitable and interesting to use also in clinical research. Some of these techniques can also be used for monitoring disease progression.” 

The new TRICALS Academy course focusses on the ‘compound muscle action potential scan’ (CMAP-scan). “This technique allows us to quantify disease progression in muscles affected by ALS.” 

CMAP-scan 

During a CMAP-scan assessment, a participant can lay or sit down comfortably. A certified professional, trained through the TRICALS Academy, will place electrodes on the skin overlying the nerves and muscles in e.g. the hands, arms or legs. These electrodes are used to deliver small electrical pulses to the nerve and to record the muscle responses. This is a well-tolerated way for the participants. “Some people even fall asleep due to repetitiveness of the pulses”.  

“By looking at how the muscles respond to various intensities of electrical pulses, we get an idea of how much the motor neurons are affected by ALS. If we look at the muscles of a person with ALS early compared  to a moment later in their disease progression, we see a different and less responsive pattern.” 

“We can thus use this as a marker in clinical trials: it allows us to compare the amount of motor neurons in the muscles of people receiving the tested drug and people receiving a placebo.” 

TRICALS Academy 

“To learn such a new technique you need both expertise and experience. With the TRICALS Academy we try to put this all together into one platform. First the professionals follow the online course, and during the face-to-face training we give them a place to practice their skills live. Afterwards, they also practice the technique at their own site. Using the TRICALS Academy we can make sure that the procedures are applied in the same way. This is done to decrease the methodological variability in the measurements, making the results of a clinical study more reliable.” 

Innovations 

The TRICALS Academy constantly tries to look for ways to improve outcome measures for clinical trials and make them more efficient. “The course on electrophysiological assessments is the perfect addition to the TRICALS Academy, as a new innovative measure.” 

The technique will be directly put into use as an outcome measure in the next clinical trial supported by TRICALS. “We hope that in the future more clinical trials will include electrophysiological assessments as an outcome measure. It has the potential to see the effects of a drug on loss of motor function, making it a beneficial to ALS clinical research.” 

New courses 

The TRICALS Academy aims to continue this line of work. Currently we are working on the next course of the Academy, on the ENCALS Risk score, another innovative measure. But also, current courses are constantly being renewed. We hope to launch seven translations of the ALSFRS-R to the TRICALS Academy very soon, making the assessment more accessible for people living with ALS.