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NeuroQuantix by Cerebral Innovations

Power your movement-disorder trial with fewer patients.

NeuroQuantix measures one fit-for-purpose kinematic endpoint from a brief drawing assessment on a tablet. The metric is specified a priori for your indication and mechanism. It runs beside the clinician-rated scale that anchors your program and is locked in the statistical analysis plan before first patient in. Published reliability and sensitivity-to-change data for the implemented metrics set the enrollment math.

Built to 21 CFR Part 11 and EU GMP Annex 11 standards, with CDISC-compatible exports. Evidence mapped in a scoping review of 120 studies in Movement Disorders Clinical Practice.

A priori
one endpoint, specified per mechanism
locked in the statistical analysis plan
COA
fit-for-purpose evidence package
assembled for the FDA COA framework
Part 11
and EU Annex 11 by design
CDISC-compatible exports
200+
published studies in our evidence database
standardized from our scoping review in Movement Disorders Clinical Practice
40+
CNS clinical trials, hands-on experience
Global regulatory experience

How does NeuroQuantix work inside a trial?

A patient completes a brief drawing assessment on a tablet at visits you already have. One kinematic metric, specified a priori for your mechanism, is the endpoint. 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. Its concept of interest and context of use are documented the way the FDA clinical outcome assessment (COA) framework describes.

1. Patient draws a spiralTremor 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 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 are on the platform page. The published evidence for each implemented metric is on the research page.

Why do movement disorder trials need so many patients?

Enrollment is set by measurement error. A trained rater assigns one whole number per item, once per visit. Floor and ceiling effects and drift between sites add to that error. Kinematics are computed, not rated, so rater drift and assessor bias do not enter the primary metric. Published evidence for the implemented metrics:

Test-retest reliability
ICC 0.97

Test-retest ICC 0.97 for tablet-measured spiral tremor amplitude in essential tremor, versus 0.90 for clinician Fahn-Tolosa-Marín ratings of the same spirals. Natural tremor variability narrowed the gap: the minimum detectable change was 51% of the initial assessment for the tablet and 67% for the ratings

Elble & Ellenbogen, 2017, Tremor and Other Hyperkinetic Movements
Projected sample, within-subject ET design
9 vs up to 28

In a within-subject ethanol challenge in essential tremor, sample size projections were 9 patients with the computerized velocity spectral peak versus up to 28 with a single visual rater, to detect a 50% tremor reduction at 95% power

Haubenberger et al., 2011, Movement Disorders
PD discrimination
AUC 0.862

AUC 0.862 for diagnostic discrimination of Parkinson disease from controls with the Composite Index of Speed and Pen-pressure

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

Responsiveness to levodopa, ethanol, MR-guided focused ultrasound thalamotomy, and deep brain stimulation reported in 6 of the 120 reviewed studies, in Parkinson disease and essential tremor populations

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. In a within-subject ethanol challenge in essential tremor, sample size projections were 9 patients with the computerized velocity spectral peak versus up to 28 with a single visual rater, to detect a 50% tremor reduction at 95% power (Haubenberger et al., 2011, Movement Disorders). 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. The assessment is brief and completed at the visit. Site training takes under 30 minutes. Cerebral Innovations provisions configured iPad Pro devices for each study.

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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