Your rating scale may be hiding the treatment effect you already have
NeuroQuantix adds a fit-for-purpose kinematic endpoint to essential tremor, Parkinson disease, ataxia, and dystonia trials: one metric, specified a priori for your mechanism, measured from a brief spiral drawing on an iPad and locked in the statistical analysis plan before first patient in. Published reliability up to ICC 0.97 for the implemented metric supports powered studies with a fraction of the subjects rating scales require.
Built to 21 CFR Part 11 and EU GMP Annex 11 standards. CDISC-compatible. Designed to run alongside TETRAS, MDS-UPDRS, and SARA.
Why movement disorder trials miss on the endpoint, not the drug
A trained rater watching a task assigns one whole number. Sampled once per visit, prone to drift between sites, and bounded by floor and ceiling effects, that number is the least precise measurement in your entire data package. The consequence is a program that needs more patients, more time, and more luck than the biology requires.
Rater variability eats your effect
TETRAS inter-rater reliability sits at ICC 0.74 to 0.85 (Elble & Ellenbogen, 2017). Everything below 1.0 is error variance that your treatment effect has to overcome.
Ordinal scales compress real change
A 0 to 4 item cannot register a 20% improvement in tremor amplitude. Composite scores blur a fine-motor effect with gait and rigidity items your drug does not touch.
Enrollment math kills small programs
At standardized response means of 0.3 to 0.5, rating scales need 25 to 100 subjects per arm. Rare and gene therapy populations do not have them.
If your Phase 1 or Phase 2 fine-motor data came back noisier than expected, start with the guide on variable early-phase motor data.
What the published evidence shows
NeuroQuantix is a fit-for-purpose digital clinical outcome assessment for movement disorder clinical trials from Cerebral Innovations LLC: a single kinematic endpoint, specified a priori for the indication and mechanism, measured from a brief drawing assessment on a tablet and delivered with the fit-for-purpose evidence package the FDA clinical outcome assessment framework calls for, built to 21 CFR Part 11 and EU GMP Annex 11 standards with CDISC-compatible exports. The numbers below come from the peer-reviewed literature the platform standardizes, mapped in a scoping review of 120 studies in Movement Disorders Clinical Practice. 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.
Test-retest reliability up to ICC 0.97 for the velocity spectral peak metric in essential tremor
Haubenberger et al., 2011, Movement DisordersAs few as 9 subjects per arm at 95% power to detect a 50% tremor reduction with the velocity spectral peak metric, versus roughly 25 to 33 per arm with TETRAS
Haubenberger et al., 2011AUC 0.862 for Parkinson disease discrimination with the Composite Index of Speed and Pressure
Zham et al., 2017, Frontiers in NeurologyResponsiveness demonstrated to levodopa on/off transitions, ethanol challenge in ET, focused ultrasound thalamotomy, and DBS
Scoping review, Wang et al., 2025A standardized administration protocol that controls practice effects and rater dependence and preserves sensitivity to treatment effects.
Repeated drawing tasks can improve with practice. Unstated instructions change velocity and pressure. Different devices sample differently. Each of these is a variance source that the protocol fixes in advance so that change from baseline reflects treatment.
These controls are written into the protocol and the statistical analysis plan before first patient in.
Learning effects on repeated spiral drawing were flagged in published sponsor pilots; scoring only after a fixed number of practice spirals moves the measurement past the steepest part of the learning curve.
63% of the 120 reviewed studies did not state whether patients were told to prioritize speed or accuracy. The instruction changes velocity and pressure metrics, so it is fixed and scripted.
A short baseline series establishes each patient's plateau so that change from baseline reflects treatment rather than task learning.
Tremor spectral metrics (frequency, amplitude) are less sensitive to task learning than time or geometry metrics; the endpoint is pre-specified per indication and mechanism.
Documented configuration across iPad Pro and Wacom hardware with quality flags for cross-device interpretability.
Kinematics are computed, not rated, so rater drift and assessor bias do not enter the primary metric.
Exploratory first, secondary next, qualified later
Nobody swaps a primary endpoint on a novel measure. The path that works is to run the kinematic endpoint beside the rating scale in the study you are planning now, generate within-program evidence, and promote it as that evidence accumulates.
- Pre-specified metric per mechanism
- Same visits as the rating scale
- SAP language and site training supplied
- CDISC export into your EDC
- Within-program reliability and responsiveness
- Concurrent validity against your anchor scale
- Type C meeting preparation
- COA/DDT pathway or EMA qualification
- Cross-program evidence
- Central rater program for the anchor scale
Questions sponsors ask first
How does a sponsor add NeuroQuantix to a trial that is already being planned?
As a pre-specified exploratory or secondary endpoint alongside the established rating scale. The protocol keeps TETRAS, MDS-UPDRS, or SARA as the regulatory anchor and adds a brief spiral drawing assessment at the same visits. The endpoint is specified a priori for the mechanism; endpoint definition language, the statistical analysis plan section, site training, and the data transfer specification are supplied. Typical time from scoping to first-patient-ready is measured in weeks, not quarters.
Can an objective kinematic endpoint reduce the number of patients we need?
Published data support it for tremor. Haubenberger and colleagues reported that the velocity spectral peak metric requires as few as 9 subjects per arm at 95% power to detect a 50% tremor reduction, compared with roughly 25 to 33 per arm using TETRAS. Whether that holds for your compound depends on the mechanism and the metric pre-specified, which is what the briefing works out.
How does NeuroQuantix fit the FDA clinical outcome assessment framework?
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 Cerebral Innovations prepares the evidence package and supports Type C meeting preparation.
What does this add to site burden?
A tablet and a stylus at visits you already have: a brief drawing assessment, with site staff operational in under 30 minutes of training. No wearables to charge, ship, or return, and no multi-day compliance window.
How are practice effects handled?
A standardized administration protocol that controls practice effects and rater dependence and preserves sensitivity to treatment effects. Concretely: fixed familiarization trials before the scored trial, a scripted speed-versus-accuracy instruction, a run-in baseline, and an endpoint metric chosen a priori for robustness to task learning.
What does an engagement cost and how does it start?
Engagements are scoped per study: endpoint consulting plus platform access for one indication and one trial, with pricing set by number of sites and subjects. The first step is a 20-minute technical briefing; the second is a written pilot scope. There is no charge for either.
More in the full list of questions to ask before adopting a digital motor endpoint.
Put NeuroQuantix in your next study
Most sponsors start with the brief, take a 20-minute briefing, and then scope NeuroQuantix as an exploratory endpoint in a study already being planned. Pick the step that matches where you are.
Get the Scientific Brief
Evidence table, protocol, compliance, and a sample size worked example. For you and your biostatistician.
Book a 20-minute technical briefing
Bring your indication and current endpoints. You leave with a view of which kinematic metrics would be pre-specified for your mechanism, what the power math looks like, and whether a pilot makes sense. No slides, no pitch.
Pick a timeRequest a pilot evaluation
Scope the endpoint for one indication and one upcoming study. You get endpoint definition language, an integration plan, and a timeline in writing.
Start a pilot request