A unique battery of CNS tests developed at CHDR
More than 27 years of experience and dedicated studies have allowed CHDR to build a proprietary CNS test battery with the most sensitive and specific validated CNS tests the NeuroCart®. The computerised system rapidly and unequivocally quantifies a wide range of neurophysiological and neuropsychological effects of CNS-active compounds and provides data-intensive quantitative information on CNS-safety pharmacodynamics and pharmacological mechanisms of action. The NeuroCart® is a compact and mobile multimodal test cart, with three different work tables, one for the operator, one for the subject, and one for the research nurse. The NeuroCart® covers all drug-responsive CNS-domains, including cognitive, neurophysiological, subjective, and autonomic tests.
- Based on numerous in-house studies and systematic literature reviews
- Purpose-built for ease and flexibility
- Reliable data collection and handling
- Frequently repeatable for direct comparisons of CNS-effects with plasma drug levels and side effects (pharmacokinetic/pharmacodynamic modelling)
- Computer-based, versatile and flexible, with easily adaptable software and hardware
- Provides data-intensive quantitative information on CNS-safety pharmacodynamics and pharmacological mechanisms of action
Most tests require only a few minutes to perform, and can be repeated frequently with minimal practice effects. The battery can be integrated in all early drug studies, from first-in-human to proof-of-concept. The logistics of performance and analysis of the tests is (semi) automated, which allows a very rapid turnover and (interim) reporting of the data.
- Saccadic and smooth pursuit eye movement
- Cognitive and memory testing
- Adaptive tracking
- Finger tapping
- Body sway
- Visual analogue scales
- Psychometric questionnaires
- Autonomic function tests (pupillometry, heart rate variability)
- Other CNS function tests like Symbol Digit Substitution Test, Critical Flicker Fusion, Stroop conflict task, etc.
Body sway test (subject with eyes closed).
Assesment of eye movement.
The measuring assistant (operating the NeuroCart®) and the subject.
Cognitive and memory testing.
The integrated systems for data management, statistics and data reporting allow efficient and high quality processing of the data generated by the NeuroCart®. Our data management software, Promasys®, is an integrated software solution and used as the central database system for all clinical trial data. The close coupling between the NeuroCart® and Promasys® allows quality controlled, blinded interim reports that can be used for dose escalation decisions and the short processing times also allow databases to be closed earlier.
Features of the NeuroCart® compared to other Cognitive Test Batteries
- The normal values have been assessed for the tests included in the NeuroCart®. Also the Minimal Detectable Effect Sizes (MDES) have been calculated for the different tests. These MDES values are compared to the effects of different positive controls, to allow the interpretation of a newly tested drug.
- Over the years the software and the hardware of the NeuroCart® has been upgraded to the current standards. All tests are extensively validated on each new NeuroCart®. Outcomes are comparable between NeuroCart® versions, which results in a large, reliable set of reference values.
CHDR’s related research experience:
Zoethout RWM, Delgado WL, Ippel AE, Dahan A, Van Gerven JMA. Functional biomarkers for the acute effects of alcohol on the central nervous system in healthy volunteers. Br J Clin Pharmacol 2011?71:331-50