Twelve questions to ask before adopting a digital motor endpoint

Evidence is assembled for the FDA clinical outcome assessment qualification framework and for inclusion in a sponsor's COA dossier: reliability, validity, and sensitivity to change for the stated context of use, under a standardized administration protocol. The endpoint enters a program as a pre-specified exploratory or secondary measure within the IND, and the evidence package is written to the concept of interest and context of use. EMA has qualified a digital endpoint (stride velocity in Duchenne) as a primary endpoint, which is the precedent sponsors cite for where the path leads.

NeuroQuantix is designed to run alongside the clinician-rated scale that anchors the program, adding continuous, rater-independent measurement of the domain the therapy targets. TETRAS, MDS-UPDRS, SARA, and BFMDRS carry regulatory precedent and clinical interpretability; the kinematic endpoint runs beside the scale, adds sensitivity, and is promoted from exploratory to secondary as within-program evidence accumulates.

Real, and handled in the protocol rather than ignored. A standardized administration protocol that controls practice effects and rater dependence and preserves sensitivity to treatment effects. The controls are fixed familiarization trials, a scripted speed-versus-accuracy instruction, a run-in baseline to plateau, and an endpoint metric chosen a priori for robustness to task learning. A published sponsor pilot of spiral drawing flagged learning effects precisely because it did not use these controls.

The NeuroQuantix methodology was standardized from the analysis in our published scoping review of digitized spiral analysis and is maintained against an evidence database of 200+ published studies. The scoping review in Movement Disorders Clinical Practice maps test-retest ICC up to 0.97 in essential tremor, AUC 0.862 for Parkinson disease discrimination, and responsiveness to levodopa, DBS, and focused ultrasound, each for a metric NeuroQuantix implements. The research page lists every finding with its source.

NeuroQuantix delivers a fit-for-purpose kinematic endpoint: one metric, specified a priori for the indication and the mechanism of action, with the concept of interest, context of use, and supporting evidence documented in the form the FDA clinical outcome assessment framework describes. The endpoint is pre-specified before first patient in and locked in the statistical analysis plan. Additional kinematic measures are collected for exploratory analysis and reported as such. A frequency-specific tremor drug gets a tremor spectral metric; a bradykinesia drug gets a velocity metric. The rules that interpret the measures are literature-graded and auditable.

A tablet and stylus at visits you already have: a brief drawing assessment, under 30 minutes to train a site. No wearables to charge, ship, or recover, and no multi-day home-monitoring compliance to manage.

CDISC-compatible exports, API transfer to common EDC systems, and audit trails that satisfy 21 CFR Part 11 and EU GMP Annex 11. Data provenance for every value: device, sampling rate, protocol version, and the rule and citation behind any derived score.

The platform is validated across iPad Pro and Wacom digitizer hardware with documented resolution differences and quality flags on each metric for cross-device interpretability. Device configuration is locked per site in the protocol.

Yes. A tablet assessment captures identical data at a site, a satellite clinic, or a home visit. Fully unsupervised home use is possible but should be introduced only after in-clinic retest data exist for your population.

Endpoint definition language for the protocol, the statistical analysis plan section, a fit-for-purpose evidence dossier for the context of use, and preparation for Type C or pre-IND discussion. Cerebral Innovations also runs central rater programs for the anchor scale, so the two endpoints are managed together.

Scoped per study: endpoint consulting plus platform access for one indication and one trial, priced by number of sites and subjects. The technical briefing and the written pilot scope are free. We publish the engagement structure rather than a rate card because the consulting component varies with what your program already has.

Add it as a pre-specified exploratory endpoint in a study you are already planning. You keep your primary and secondary endpoints, you generate within-program evidence on sensitivity in your own population, and you decide about promotion with data rather than promises.