NeuroQuantix Spiral Analysis Platform
NeuroQuantix is a regulatory-grade digital endpoint platform that extracts 397 kinematic metrics across 12 measurement domains from a brief spiral drawing assessment. Built on 44 years of published digitized spiral analysis research, the platform delivers pre-specified endpoints for CNS clinical trials with substantial measurement sensitivity that complements traditional rating scales.
Built on the digitized Archimedes spiral drawing test (DAST), also known as computerized spiral analysis (CSA) or digital spirography. 21 CFR Part 11 and EU GMP Annex 11 compatible, and CDISC-compatible for global regulatory submission readiness.
Built on 300+ peer-reviewed studies. Our scoping review of 120 studies in Movement Disorders Clinical Practice maps the evidence base and the gaps NeuroQuantix addresses.
The measurement gap in CNS clinical trials
CNS clinical trials fail at a higher rate than any other therapeutic area, and endpoint sensitivity is a major lever in changing that. Traditional clinician-rated scales — including TETRAS, MDS-UPDRS, and BFMDRS — bring decades of regulatory precedent and clinical interpretability. Continuous digital kinematic measurement complements them with the high-frequency precision needed to detect smaller treatment effects. The resulting rater variability that remains is the single largest controllable source of noise in CNS trial endpoints.
The result is a fundamental mismatch: treatments may be working, but the measurement tools cannot see it. Clinical trials fail not because the drug failed, but because the endpoint failed. That is why endpoint strategy must start with measurement precision.
Traditional vs. NeuroQuantix
Technical Capabilities
Every aspect of the platform is engineered for regulatory-grade precision, clinical trial deployment, and transparent scientific interpretation. Aligned with DiME principles for digital clinical measures.
Pre-Specified Endpoint Selection
Twelve kinematic domains (tremor, velocity, pressure, motor control, pen tilt, and more) provide the measurement depth to select a pre-specified endpoint matched to your treatment mechanism and indication. Not a fishing expedition; a targeted, defensible selection.
Transparent, Auditable Interpretation
Every diagnostic rule is grounded in peer-reviewed literature with full citation provenance and evidence grading. Transparent, auditable, and explainable. Designed to withstand regulatory scrutiny, not an opaque machine learning black box.
Pen Tilt Tremor: 3D Hand Dynamics
Captures stylus altitude and azimuth tremor — a dimension most digital biomarker platforms miss entirely. Published data shows pen tilt-pressure analysis is highly discriminative for PD detection.
Frequency-Band Decomposition
Decomposes tremor across frequency bands for robust differential characterization by tremor type.
Cross-Device Validated
Validated across iPad Pro (240 Hz) and Wacom digitizer hardware with documented spatial resolution differences. Quality flags classify each metric for cross-device interpretability.
Broad Indication Coverage
Validated across essential tremor, Parkinson disease, dystonia, cerebellar ataxia, and more. Differential likelihood profiles enable enrollment quality screening and condition-specific endpoint selection.
Use cases across global CNS programs
Designed for regulatory submissions across global jurisdictions including FDA, EMA, and Health Canada.
Registration Trial Endpoints
Pre-specified primary or secondary endpoints for Phase 2/3 efficacy trials across ET, PD, dystonia, and ataxia. Published effect sizes enable powered studies with fewer subjects.
Phase 1-2 De-Risking
Exploratory digital endpoints in early-phase trials to establish dose-response signal. De-risk your Phase 3 endpoint strategy before committing enrollment resources.
Gene Therapy & Rare Disease
Substantial effect sizes from digitized spiral analysis enable powered studies with smaller cohorts. Designed for populations where traditional scales require more subjects than are available.
Drug Safety Monitoring
Quantify drug-induced movement disorders as adverse event signals. Detect subtle motor changes before they reach clinical thresholds on subjective rating scales.
Natural History Studies
Establish endpoint performance and disease trajectory data to support a future IND. Strong test-retest reliability enables longitudinal tracking of motor progression.
Neuromodulation Outcomes
Objective motor assessment for DBS programming optimization. Published validation demonstrates discrimination of stimulation on vs. off states.
Built for global submission readiness
NeuroQuantix is built to standards (21 CFR Part 11, EU GMP Annex 11, GxP, GAMP 5, CDISC) accepted across global regulatory jurisdictions, with parallel 510(k)/De Novo device clearance for clinical practice. The platform is being developed as a digital health technology for drug development. Our regulatory strategy team supports submissions across FDA, EMA, and Health Canada programs.
Standards-Aligned Compliance
Built to internationally recognized standards: 21 CFR Part 11 (electronic records), EU GMP Annex 11 (computerized systems), GxP process quality, GAMP 5 risk-based validation, and CDISC data structure. Designed for inclusion in submissions across global regulatory jurisdictions.
Device Clearance (510(k) / De Novo)
Class II device clearance for clinical practice use. Predicate device landscape includes Kinesia, StrivePD, and PKG, establishing a regulatory pathway for digital motor assessment tools.
Fits your existing trial infrastructure
NeuroQuantix is designed to deploy within the systems and workflows your clinical operations team already uses.
EDC Integration
Compatible with Medidata Rave, Oracle Clinical, and Veeva Vault. Standard API-based data transfer to your electronic data capture system.
eCOA Platform Ready
CDISC-compliant data exports in ODM format. Integrates with existing electronic Clinical Outcome Assessment platforms.
Site Deployment
iPad Pro (240 Hz) or Wacom digitizer hardware. Minimal site training, under 30 minutes to operational readiness.
CDISC Data Format
Regulatory submission-ready data outputs in CDISC standard formats (cdisc.org). Structured for direct inclusion in NDA/BLA submissions.
Multi-Site Scalable
Cloud-hosted platform with site-level access control, real-time data monitoring, and centralized quality dashboards.
Complete Audit Trail
Every data capture, modification, and access event logged with timestamps, user identity, and reason codes per 21 CFR Part 11.
Published Scoping Review
Scoping review of 120 studies (1,407 citations screened) published in Movement Disorders Clinical Practice. Maps the evidence on reliability, validity, and responsiveness of digitized spiral analysis, and identifies the gaps NeuroQuantix fills.
Read the scoping review in Movement Disorders Clinical PracticePreliminary Clinical Data
Cross-device validation with N=40 (PD vs. healthy controls) showing strong discriminative performance on key motor metrics. Published literature supports high motor smoothness discrimination in stroke and strong test-retest reliability for tremor frequency.
Preliminary data. Prospective validation in progress.
Planned Validation Study
N=300 prospective, multi-site, observational study designed across four academic medical centers. Nine condition groups with structured longitudinal follow-up.
Study designed. Enrollment planned.
Indication Coverage
Published literature supports digitized spiral analysis across these indications. NeuroQuantix delivers pre-specified endpoints matched to your specific condition. View all conditions with evidence details.
Movement Disorders
Neurodegenerative
Demyelinating & Acquired
Reference
Frequently Asked Questions
What is NeuroQuantix?
NeuroQuantix is a regulatory-grade digital endpoint platform that extracts 397 kinematic metrics across 12 measurement domains from a brief spiral drawing assessment on an iPad Pro or Wacom digitizer. Built on 44 years of published digitized spiral analysis research (300+ peer-reviewed studies), it delivers pre-specified, literature-backed endpoints for CNS clinical trials. The platform is 21 CFR Part 11 and EU GMP Annex 11 compatible, designed for global regulatory submission readiness.
How many metrics does NeuroQuantix extract?
NeuroQuantix extracts 397 kinematic metrics across 12 functional domains: tremor, velocity, acceleration, jerk, pressure, pen tilt, spatial trajectory, motor smoothness, frequency decomposition, timing, coordination, and drawing accuracy. Each metric is mapped to published literature with evidence provenance. The platform applies 82 evidence-graded diagnostic rules (graded A through D) to interpret these metrics across 23 neurological conditions.
What conditions can NeuroQuantix assess?
NeuroQuantix provides differential likelihood profiles across 23 neurological conditions including essential tremor, Parkinson disease, dystonic tremor, cerebellar ataxia, functional tremor, orthostatic tremor, Holmes tremor, tardive dyskinesia, Huntington disease, Wilson disease, multiple sclerosis tremor, and others. The 82 diagnostic rules differentiate conditions based on kinematic signatures specific to each disorder.
How does NeuroQuantix compare to TETRAS and MDS-UPDRS?
Traditional clinician-rated scales like TETRAS and MDS-UPDRS bring decades of regulatory precedent and clinical interpretability. NeuroQuantix complements them with continuous, high-frequency kinematic measurement that adds the precision needed to detect smaller treatment effects. Many modern trial designs use both — a traditional scale for regulatory continuity, plus digital kinematic endpoints to improve sensitivity and increase the probability of detecting real treatment effects.
Is NeuroQuantix FDA compliant?
NeuroQuantix is designed for 21 CFR Part 11 and EU GMP Annex 11 compliance with complete audit trails, role-based access controls, electronic signature capability, and HIPAA-compliant data security. Data exports are CDISC-compatible for direct inclusion in NDA/BLA regulatory submissions across global jurisdictions.
What is the digitized Archimedes spiral drawing test (DAST)?
The digitized Archimedes spiral drawing test (DAST), also called computerized spiral analysis (CSA) or digital spirography, is a clinical assessment where patients draw an Archimedes spiral on a digital tablet. NeuroQuantix captures this task at 240 samples per second and extracts 397 kinematic metrics across 12 measurement domains. A scoping review of 120 studies maps the evidence base (Wang et al., 2025).
Can digital spiral analysis reduce clinical trial sample sizes?
Yes. Higher measurement sensitivity from continuous kinematic data enables powered studies with smaller cohorts. Published spiral analysis literature shows substantially improved effect sizes that translate directly to smaller enrollment requirements. This is particularly valuable for gene therapy and rare disease programs where patient populations are limited.
How does NeuroQuantix compare to accelerometer-based motor assessment?
Unlike accelerometer-based platforms (such as Kinesia) that measure body-worn sensor data, NeuroQuantix captures the biomechanical signature of a goal-directed motor task. This includes pen tilt tremor (3D hand dynamics), pressure dynamics, spatial trajectory, and motor planning metrics that wearable accelerometers cannot measure. Published literature shows pen tilt-pressure analysis is highly discriminative for PD detection.
Pair the platform with expert consulting
Endpoint Consulting
Strategic endpoint selection for your specific therapeutic target and regulatory pathway.
Central Rater Committees
Calibrated rater infrastructure that protects data integrity across every site.
Regulatory Strategy
COA/DDT qualification and global regulatory navigation for digital endpoints.
FaceWise
Memory consolidation assessment for cognitive decline and Alzheimer trials.
See what precision measurement reveals
Request a technical overview, sample data outputs, or discuss how NeuroQuantix integrates into your trial design and regulatory strategy, for any global market.