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NeuroQuantix by Cerebral Innovations

Power your movement-disorder trial with fewer patients.

Rating scales carry rater error and ordinal compression in every observation. NeuroQuantix adds a fit-for-purpose kinematic endpoint beside them: 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 for regulatory submission from day one: 21 CFR Part 11, EU GMP Annex 11, GxP, CDISC. Evidence mapped in a scoping review of 120 studies in Movement Disorders Clinical Practice.

200+
published studies in our evidence database
standardized from our scoping review in Movement Disorders Clinical Practice
A priori
one endpoint, specified per mechanism
locked in the statistical analysis plan
Part 11
and EU Annex 11 by design
CDISC-compatible exports
COA
fit-for-purpose evidence package
assembled for the FDA COA framework
40+
CNS trials led or supported
FDA, EMA, Health Canada programs

One drawing. One pre-specified endpoint. No wearables.

The assessment happens at visits you already have. The endpoint is one metric, specified a priori for your mechanism and locked in the statistical analysis plan, with its concept of interest and context of use documented the way the FDA clinical outcome assessment framework describes. Additional kinematic measures are collected for exploratory analysis and reported as such.

1. Patient draws a spiral (30 s)Tremor amplitudeTremor frequencyVelocityPressurePen tiltSmoothness2. Kinematic metrics computedPRE-SPECIFIED ENDPOINTTremor amplitudechange from plateau baselineSame visits as the rating scaleSAP language suppliedCDISC export to your EDC21 CFR Part 11 audit trail3. The a priori endpoint, locked in the SAP

Site burden

A brief drawing assessment on iPad Pro or Wacom digitizer at existing visits. Under 30 minutes to train a site.

Practice effects

A standardized administration protocol that controls practice effects and rater dependence and preserves sensitivity to treatment effects.

Data flow

Audit-trailed capture, CDISC-compatible export, API transfer to your EDC. Built to 21 CFR Part 11 and EU GMP Annex 11.

Protocol details and the shown-versus-validating table are on the platform page and the research page.

Why the endpoint, not the drug, is often what missed

A trained rater assigns one whole number per item, once per visit, with floor and ceiling effects and drift between sites. Everything below a reliability of 1.0 is error the treatment effect has to overcome. Computed kinematics remove the rater from the measurement. The published contrast for essential tremor:

Test-retest reliability
ICC 0.97

Test-retest reliability up to ICC 0.97 for the velocity spectral peak metric in essential tremor

Haubenberger et al., 2011, Movement Disorders
Subjects per arm at 95% power
9 vs 25-33

As 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., 2011
PD discrimination
AUC 0.862

AUC 0.862 for Parkinson disease discrimination with the Composite Index of Speed and Pressure

Zham et al., 2017, Frontiers in Neurology
Responsiveness shown for
DBS, levodopa, FUS

Responsiveness demonstrated to levodopa on/off transitions, ethanol challenge in ET, focused ultrasound thalamotomy, and DBS

Scoping review, Wang et al., 2025

Questions sponsors ask first

What is NeuroQuantix?

NeuroQuantix is a fit-for-purpose digital clinical outcome assessment for movement disorder trials from Cerebral Innovations LLC. A patient completes a brief drawing assessment on an iPad; one kinematic metric, specified a priori for the drug's mechanism, is the trial endpoint and runs alongside the clinician-rated scale. It is built to 21 CFR Part 11 and EU GMP Annex 11 standards with CDISC-compatible exports.

How does an objective motor endpoint reduce the number of patients a trial needs?

Enrollment is set by measurement error. TETRAS inter-rater reliability is ICC 0.74 to 0.85; the published velocity spectral peak metric reaches ICC 0.97. In the published essential tremor example, that difference is 9 subjects per arm at 95% power versus 25 to 33 with TETRAS for a 50% tremor reduction. Your own numbers depend on the mechanism and the metric pre-specified.

How does NeuroQuantix work alongside TETRAS or MDS-UPDRS?

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. It enters a program as a pre-specified exploratory or secondary endpoint within the IND, with the evidence for its context of use assembled for the FDA clinical outcome assessment framework and the sponsor's COA dossier.

What does it add to site burden?

A tablet and a stylus at visits you already have: a brief drawing assessment, and under 30 minutes to train a site. No wearables to ship, charge, or recover.

Put NeuroQuantix in your next study

A 20-minute briefing tells you which metric would be pre-specified for your mechanism and what the enrollment math looks like. If it fits, you get a written pilot scope. Both are free.

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