After a scientific research confirmed the NeuroMotor Pen can be utilized to differentiate Parkinson’s Illness (PD) from different motion issues, with an accuracy of 80% and sensitivity of 95%, Med-Tech Innovation Information caught up with Manus Neurodynamica CEO Dr Rutger Zietsma, to seek out out its implications.
Are you able to summarise what the current scientific research have proven with the NeuroMotor Pen (NMP)?
Parkinson’s diagnostic scientific consequence validation
A sequence of bench testing and scientific validation research have taken place since 2011 in Europe with opinion leaders within the subject of Motion Problems in Amsterdam, Groningen, Dublin and Newcastle-upon-Tyne, demonstrating that there are particular biomarkers for the illness processes in PD that NMP is uniquely in a position to seize.
The newest research accomplished in 2020 resulted in diagnostic accuracy of NMP (PD vs different motion issues) of 80% (sensitivity of 95%; specificity of 63%) in 132 undiagnosed sufferers in motion issues clinics with tremor and different motion signs, for whom it was tough to make an unequivocal diagnostic resolution and the advisor neurologist ordered a DatSCAN for affirmation. NMP was in comparison with present finest practices (specialist conclusion six months after the primary appointment, primarily based on at least DaTSCAN outcomes in addition to MDS-UPDRS scores).
It was concluded that the diagnostic accuracy of NMP (PD vs different motion issues) is 80% with a sensitivity of 95% and a specificity of 63%.
For info: Prior research have been printed in peer reviewed journals and reported the next:
- Standardised NMP drawing duties appropriate for quantification of motor talent and PD signs with NMP biomarkers;
- Correct quantification of motor talent and response to dopaminergic treatment with NMP biomarkers. Accuracy and determination have been increased than reference measures, together with Purdue pegboard job and commonplace scientific evaluation scores just like the UPDRS-III score scale. NMP quantified the presence of tremor and minute variations, which scientific specialists weren’t in a position to detect with the bare eye.
- Excessive reproducibility of motor biomarkers.
- Validation on 92 sufferers with a longtime prognosis (which is a a lot simpler diagnostic state of affairs than undiagnosed sufferers – reported above with an accuracy of 80%) resulted in classification accuracies of 82% for important tremor, 69.8% for useful tremor and 72.2% for enhanced physiological tremor.
Schizophrenia
The utility of the NMP within the evaluation of the extrapyramidal hostile results of antipsychotic medicine was validated in collaboration with The College of Edinburgh and Lothian Well being Board. Twenty-one sufferers residing with psychosis agreed to take part, gave knowledgeable consent, and have been assessed by the present commonplace clinician-rated measure, the Extrapyramidal Symptom Score Scale (ESRS), which assesses 4 varieties of drug-induced motion issues: parkinsonism, akathisia, dystonia, and tardive dyskinesia, in addition to by a standardised battery of writing assessments utilizing the Manus NeuroMotor Pen (NMP).
The outcomes confirmed that the gadget was extremely usable and acceptable to sufferers residing with psychosis, and options measured by NMP have been extremely predictive of the scientific examination findings decided by ESRS. As well as, tremor, bradykinesia and facial options of drug-induced antipsychotic hostile results have been additionally predicted by options measured by NMP.
The investigators concluded that the research means that the NMP is the primary simply transportable gadget able to making an goal analysis of the extrapyramidal hostile results of antipsychotic remedy and counsel that the NMP has scientific utility and validity to information the remedy and administration of these taking antipsychotics.
NMP affords an software in monitoring how efficient medicine are and extra importantly additionally to find the correct dose to present sufferers the optimum dose that gives all advantages however avoids the unwanted side effects. These unwanted side effects are a catastrophe that at all times creates different scientific issues – usually leading to lack of writing capability (and shedding job). Psychiatrists have identified this for 40 years and pharma firms have brushed it below the carpet till now. The market is now opening up with pharma in search of options. I’m speaking to each a pharma firm and two new teachers about trialling this necessary software on a bigger scale.
You’ve spoken to us beforehand concerning the NeuroMotor Pen getting used to deal with Parkinson’s, did you at all times envisage it might be used for different circumstances?
Sure, completely. Our preliminary focus has been on Parkinson’s prognosis and monitoring as an necessary space for which there have been robust indications {that a} resolution might be developed that’s sufficiently correct. It was important to have an preliminary focus space for R&D together with a industrial technique as a way to focus assets to ship a marketable product. I at all times envisioned diversifying as soon as the PD market, as our first beachhead, had gained adequate traction.
Nonetheless, there are lots of neurological issues that impacts the extrapyramidal system, which is the a part of the nervous system concerned with tremendous tuning voluntary motion and due to this fact result in motion abnormalities. All of those illnesses might doubtlessly profit from non-invasive evaluation of those ‘extrapyramidal results’ to help early identification, differential prognosis and remedy. Different illness areas are a number of sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Alzheimer’s illness (AD), but in addition Consideration deficit hyperactivity dysfunction (ADHD) and so forth.
One instance the place we’re already diversifying and have obtained information is the NMP use in schizophrenia, which has many parallels with PD. NMP permits the healthcare skilled to precisely and objectively quantify scores usually (subjectively) noticed by the clinician. Any affected person on antipsychotics is generally assessed six occasions per 12 months and the automated digital report protecting is a large profit as psychiatrists should not superb at protecting information – even when they’re good at observing/quantifying the motion issues.
Did you think about that may use it as a diagnostic device for neurological circumstances?
Sure, this was the intention and the primary funding together with a grant was particularly for growth of the Parkinson’s diagnostic software.
Are you able to summarise the circumstances that the neuromotor pen can now be used for?
We at the moment have a regulatory declare for Parkinson’s (PD) prognosis solely and we provide it as a PD diagnostic. We don’t market NMP for every other use but.
Nonetheless, the PD regulator declare for diagnostic signifies that NMP is just not solely in a position to affirm PD, but in addition in a position to differentiate between completely different motion issues that mimic the PD signs, similar to important tremor (ET), MS, PSP, MSA, psychogenic tremor and so forth, so the precise software is broader. In follow, NMP will assist clinicians not solely to diagnose PD, but in addition pinpoint what illnesses the sufferers could or could not endure from, primarily based on the check outcomes.
We’re additionally in a position to provide NMP as an ‘off label’ resolution in different areas of software, similar to PD monitoring or EPS evaluation in schizophrenia and so forth (principally any use an educational clinician can assume off).
In mild of those outcomes, what subsequent for Manus Neurodynamica?
- Elevated gross sales and advertising and marketing actions for the PD seaside head market.
- We count on to have at the least 5 reference centres within the UK inside 12 months’ time.
- Acquiring FDA approval within the US.
- Progressing trials with at the least one pharma firm on a industrial foundation (discussions on-going)
- In parallel, we’re creating the Alzheimer’s and schizophrenia options.
