For Physicians, Pediatricians & Sports Medicine Providers

Objective Neuro-Visual
Assessment for Pediatric
Concussion

Clinical evidence, assessment protocols, CPT reimbursement guidance, and device information for the ClearGazeTest VR-based oculomotor concussion assessment platform.

564K
Pediatric TBI-related emergency department visits annually (US)
CDC — NATIONAL CENTER FOR INJURY PREVENTION
18.3%
Annual concussion incidence in adolescents aged 13–17
PEDIATRIC EPIDEMIOLOGY — PUBLISHED LITERATURE
~30%
Develop Post-Concussion Syndrome with symptoms persisting >10 days
CLINICAL LITERATURE — MULTIPLE COHORT STUDIES
Zero
FDA-cleared objective assessment tools validated for children under age 10
FDA DEVICE DATABASE — AS OF 2026

Pediatric Concussion Epidemiology

Concussion is the most common traumatic brain injury in the pediatric population. Understanding the age-stratified incidence, mechanism distribution, and sex-specific outcomes is essential for appropriate screening, diagnosis, and management across clinical settings.

Age Group Annual Incidence Primary Mechanism Clinical Notes
0–4 years Elevated vs. older children Falls (dominant) Non-accidental trauma peaks under 12 months; limited verbal reporting
5–12 years 1.85 per 100/year Falls, organized sports No validated baseline tool; children minimize symptoms to preserve play time
13–17 years 18.3% annually Sports collision, MVA Peak incidence at 14–15; girls show worse outcomes despite lower incidence
Female vs. Male Males: higher incidence Contact sports Females: worse symptom burden, longer recovery, higher PCS rates
PCS Risk ~30% of all pediatric Symptoms >4 weeks; requires specialist management

CDC National Concussion Surveillance System (NCSS)

The CDC is actively developing the NCSS — the first national system to produce standardized incidence estimates across all age groups and settings, including unorganized sport. It cannot function without a standardized, objective assessment instrument. ClearGazeTest is designed to serve as that infrastructure layer.

Why Current Tools Are Insufficient

SCAT5, ImPACT, and King-Devick are the current clinical standards. All rely substantially on patient self-report. None are validated for children under 5. None produce an objective neurological performance metric independent of examiner variability. None have demonstrated sensitivity for subclinical injury — the majority of pediatric concussions.

The Reporting Gap

Published estimates suggest 50% or more of pediatric concussions go unreported. Contributing factors include: children concealing symptoms to preserve play eligibility; parental minimization; absence of loss of consciousness (present in <10% of cases); and symptom onset delayed by hours to days post-injury.

Post-Concussion Syndrome: Underdiagnosed in Children

PCS affects approximately 30% of concussed children. Risk factors include: female sex, prior concussion, migrainous phenotype, psychiatric comorbidity, and delayed diagnosis. PCS requires active management — vestibular rehabilitation, neuropsychological support, academic accommodation, and structured exertion protocols. Symptom questionnaires alone are insufficient to guide management.

Second Impact Syndrome

A rare but potentially catastrophic complication of repeat concussion before full neurological recovery. Diffuse cerebral edema from loss of cerebrovascular autoregulation can result in rapid herniation. Documented predominantly in pediatric and adolescent athletes. Objective clearance — not symptom resolution — is the appropriate standard for return-to-play authorization.

Pathophysiology & Neuroanatomy

Concussion produces a cascade of ionic, metabolic, and vascular disturbances that disrupt normal neural function without causing structural injury detectable on conventional imaging. The oculomotor system integrates the widest array of neural structures of any functional output — making it uniquely sensitive to diffuse and focal concussive injury.

Ionic Phase
The Initial Disruption
Mechanical deformation of the brain triggers indiscriminate release of excitatory neurotransmitters and a massive efflux of potassium with influx of calcium ions. This depolarizes neurons en masse — generating a spreading depression across cortical and subcortical circuits simultaneously. The resulting dysfunction is diffuse and immediate, preceding any structural change.
Metabolic Phase
The Energy Crisis
Restoration of ionic balance demands ATP consumption precisely when mitochondrial oxidative metabolism is impaired and cerebral blood flow is reduced. This metabolic mismatch — increased demand, decreased supply — produces the vulnerable period when a second impact is particularly dangerous. Duration: hours to days. This is the biological basis of the return-to-play protocol.
Functional Phase
Measurable Dysfunction
The ionic and metabolic disruptions produce measurable degradation of neural circuits that are sensitive to exact timing, velocity, and coordination — precisely the demands placed on the oculomotor system. Saccadic velocity slows. Pursuit gain decreases. Vergence breaks down. VOR gain shifts. These changes occur before the patient reports a symptom and persist after symptoms resolve.
Frontal Eye Fields
Voluntary saccade initiation; Brodmann area 8; disrupted by frontal TBI
PPRF + riMLF
Horizontal and vertical saccade generators; brainstem; highly sensitive to rotational TBI
Cerebellum
Flocculus / paraflocculus; pursuit gain; VOR adaptation; early loss in TBI
VOR Arc
Shortest CNS reflex arc; 3-neuron; gain reduction is first measurable TBI sign
MLF + CN IV
MLF: adduction coordination; CN IV: longest unprotected course; most commonly injured in closed head trauma

Clinical Presentation — Four Domains

Pediatric concussion presents across four symptom domains. Clinicians should systematically assess each domain — the absence of symptoms in one does not rule out significant injury in others. Cognitive and sleep symptoms may be the most actionable for school accommodation and management planning.

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Physical / Somatic

Body Symptoms

  • Headache / head pressure
  • Nausea, vomiting
  • Dizziness, imbalance
  • Visual disturbance
  • Photophobia
  • Phonophobia
  • Fatigue
  • Sleep disturbance
🧠
Cognitive

Thinking Symptoms

  • Feeling slowed / "foggy"
  • Attention difficulty
  • Memory impairment
  • Confusion
  • Word-finding difficulty
  • Slowed processing
  • Academic regression
😢
Emotional / Behavioral

Mood Symptoms

  • Irritability
  • Emotional lability
  • Anxiety
  • Depressive symptoms
  • Social withdrawal
  • Personality change
  • Loss of motivation
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Sleep

Sleep Symptoms

  • Hypersomnia
  • Insomnia
  • Fragmented sleep
  • Difficulty waking
  • Excessive daytime somnolence
  • Unrefreshing sleep
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Emergency Referral Indications — Immediate ER / Neurosurgery

Loss of consciousness
Repeated vomiting (>2 episodes)
Seizure / convulsion
Anisocoria / pupillary asymmetry
Progressive somnolence
Worsening or refractory headache
Focal neurological deficit
Cervical spine tenderness
GCS < 15 at any time

Oculomotor Biomarkers of TBI

"The oculomotor system integrates the frontal eye fields, parietal cortex, cerebellum, brainstem nuclei, basal ganglia, vestibular system, and retinal contrast processing — simultaneously, continuously, and in real time. Any insult to the brain degrades this system in specific, measurable patterns before the patient reports a single symptom."

The 12 biomarkers below represent the full oculomotor assessment profile captured by the ClearGazeTest platform. Each metric corresponds to a distinct neural pathway — enabling localization of dysfunction and differentiation between concussive and non-concussive causes of symptom presentation.


Assessment is conducted in a fully controlled VR environment at ≥120 Hz eye-tracking sampling rate. Results are compared against the patient's individual baseline and against an age-stratified normative database.

BM-01
Saccadic Latency
Time from target onset to saccade initiation
↑ in mTBI, cannabinoids, alcohol, fatigue
BM-02
Peak Saccadic Velocity
Maximum angular velocity during gaze shift
↓ in concussion, sedation, cerebellar dysfunction
BM-03
Saccadic Accuracy (Gain)
Ratio of actual to commanded displacement
Dysmetria indicates cerebellar or brainstem pathology
BM-04
Smooth Pursuit Gain
Ratio of eye velocity to target velocity
↓ in mTBI, cannabinoids, fatigue; asymmetry indicates lateralized lesion
BM-05
Fixation Stability
Micro-saccade frequency and drift during fixation
↑ drift indicates cerebellar or brainstem dysfunction
BM-06
Vergence / Convergence
Near-point convergence velocity and amplitude
NPC >6 cm pathologic; early and sensitive TBI marker
BM-07
VOR Gain
Eye velocity during simulated head movement
First measurable TBI sign; precedes all subjective symptoms
BM-08
Pupil Light Reflex
Constriction latency and amplitude, bilateral
RAPD = afferent pathway lesion; CN III involvement = efferent
BM-09
Reaction Time
Visuo-motor response latency
Global cognitive processing speed; elevated in mTBI and impairment
BM-10
Contrast Sensitivity
Spatial frequency detection threshold
↓ 30–50% acute cannabis exposure; ↓ in photophobic TBI
BM-11
Optokinetic Response
Slow-phase and fast-phase OKN parameters
Asymmetry indicates MCA territory or brainstem involvement
BM-12
Inter-Saccadic Interval
Fixation duration between sequential saccades
Rapid naming correlate; disrupted in PCS and cognitive load

ClearGazeTest Assessment Protocol

The ClearGazeTest assessment is a structured, five-minute VR-based protocol delivering standardized stimuli across 10 sequential modules. Total assessment time: 4–5 minutes. No specialized technician required. Applicable from age 5. Results exportable to EMR.

01
~20 SEC
Calibration & Baseline Fixation
Establish visual axis, foveation alignment, and baseline pupil diameter. Fixation dot traces slow spiral ±5°. Metrics: fixation stability, micro-saccades, drift, baseline pupil size.
02
~30 SEC
Pupillary Reflex
Dark adaptation (3s) → bilateral flash stimulus → alternating monocular stimulation → near response. Metrics: PLR latency, constriction/dilation velocity, RAPD, near reflex.
03–04
~45 SEC
Horizontal & Vertical Saccades
Targets at 90°/180° horizontal; 30°/60° vertical. Center → left → right; center → up → down sequences. Metrics: velocity, accuracy, overshoot, nystagmus, adduction deficit.
05–06
~45 SEC
Smooth Pursuit + OKN
Moving target: L→R, U→D, circle, figure-8. Moving grating drum: L/R/U/D. Metrics: pursuit gain, catch-up saccades, asymmetry, OKN slow-phase velocity, frequency.
07–10
~90 SEC
Vergence, Reaction, VOR, Obliques
Near convergence (2m→20cm). Single triggered reaction-time event. VOR: stationary target, moving background. Oblique: diagonal targets. Full biomarker profile completed.

Current Standard (SCAT5 / King-Devick / ImPACT)

  • Symptom checklist — fully patient-reported
  • Results vary by examiner and setting
  • Not validated below age 10
  • Cannot detect subclinical neurological dysfunction
  • No objective metric for legal or return-to-play clearance
  • King-Devick: single metric (rapid number naming)
  • No normative database for comparison

ClearGazeTest Objective Assessment

  • 12 quantitative oculomotor biomarkers — no self-report required
  • Identical stimulus delivered every administration
  • Designed for children from age 5 upward
  • Detects subclinical dysfunction before symptom onset
  • Quantitative, documentable, legally defensible output
  • Full oculomotor profile + reaction time + VOR + pupillometry
  • Individual baseline + age-stratified normative database comparison

CPT Reimbursement Guide

ClearGazeTest assessments are billable under existing CPT codes — no new codes required. The following codes are applicable depending on clinical context and the scope of assessment delivered. Verify coverage with individual payers; codes and rates are as of 2026.

CPT Code Description Applicable Setting Est. Reimbursement
96132 Neuropsychological testing evaluation, first hour, physician Pediatrics, neurology, sports medicine $175–$350
96133 Neuropsychological testing, each additional 30 minutes Add-on to 96132 $80–$150
92083 Visual field examination, unilateral or bilateral Ophthalmology, optometry $60–$120
92060 Sensorimotor examination — strabismus, vergence testing Ophthalmology $85–$160
95930 Visual evoked potential testing, bilateral Neurology, neuro-ophthalmology $120–$200
97750 Physical performance test or measurement — reaction time component Sports medicine, PM&R $50–$100
99173 Visual acuity screening — high volume, primary care Pediatrics, primary care $15–$30
DoD / VA TBI evaluation episode — DRG-based inpatient + outpatient codes Military, veteran health $400–$1,200
Practice Revenue Modeling: A practice billing 6–8 ClearGazeTest assessments per day at an average of $200 (96132 + 92060 combined) generates approximately $300,000–$400,000 in annual gross billings from this single service line. The ClearGazeTest system purchase price is recovered within 9–12 billing days. The $199/month service contract represents <1.2% of annual billing volume — less than a single afternoon of assessments.

Regulatory Pathway

ClearGazeTest is pursuing a phased FDA regulatory strategy designed to enable immediate clinical deployment under Class I, with progressive clearance that elevates clinical credibility and unlocks additional reimbursement categories.

CURRENT
PHASE 1 — ACTIVE
FDA Class I
510(k) Exempt — Software-Based Assessment
Software-based neurocognitive screening tool. No predicate device required. Fastest available regulatory pathway. Analogous to King-Devick and SCAT5 digital assessment platforms. Clinical deployments begin immediately under this classification.
PHASE 2 — 12–24 MONTHS
FDA Class II
510(k) Submission — Device Classification
EEG module addition triggers Class II requirement. Predicate: EEG-based neurocognitive assessment devices. Substantially elevates payer acceptance, institutional procurement confidence, and CPT reimbursement rates. Enables VA and hospital system deployments.
PHASE 3 — 24–36 MONTHS
Breakthrough Device
De Novo Designation — Pending Outcomes Data
Contingent on demonstration of sensitivity/specificity superiority versus SCAT5 in pediatric population. FDA Breakthrough Device Designation shortens review by 6–12 months and provides direct FDA engagement throughout development. Signals clinical validity to all payer categories.

Device Pricing & Commercial Model

ClearGazeTest is sold — not leased. Practices purchase the system outright and pay a monthly service contract that covers software updates, normative database access, cloud storage, and technical support. The purchase price is recovered rapidly through standard CPT billing.

One-Time Purchase Price
$14,500
Full ClearGazeTest system including VR hardware, RIDE software integration, and calibration setup. Section 179 eligible for Year 1 tax deduction. No specialized installation required.
Monthly Service Contract
$199/mo
Software updates, normative database access (age-stratified, continuously updated), cloud storage, technical support, and annual recalibration. Institutional tier: $499/mo with multi-device dashboard and outcomes analytics.
Per-Assessment Data Fee
$15–25
Optional per-test fee for AI-benchmarked report against full normative database. Powers the proprietary normative dataset that grows in value with every assessment performed globally.

Return on Investment

A single ClearGazeTest unit billing 6–8 assessments per day at $100 average net reimbursement recovers the full purchase price within 9–12 billing days. The service contract represents less than a single afternoon of billing volume annually. It keeps the practice's system current, the clinician supported, and the normative database building — compounding in value with every patient assessed.

<12
billing days to
full purchase recovery

Supporting Evidence

The ClearGazeTest platform is grounded in peer-reviewed oculomotor neuroscience. The following domains represent the strongest recurring signals in the concussion and mTBI literature supporting the biomarker strategy.

Saccadometry
Saccadic Latency & Velocity as mTBI Biomarkers
Consistent across multiple cohorts: saccadic latency increases and peak velocity decreases following mTBI, correlating with symptom severity and recovery trajectory. Changes persist beyond subjective symptom resolution — supporting objective assessment as clearance criterion.
Smooth Pursuit
Cortical Motion Processing Disruption in Concussion
Smooth pursuit gain reduction and increased catch-up saccade frequency are among the most sensitive early markers of concussive injury. Originating in V5/MT and MST, pursuit deficits localize to cortical motion processing areas vulnerable to diffuse axonal injury.
Vergence
Convergence Insufficiency as Concussion Marker
Near-point convergence distance >6 cm is pathologic. Convergence insufficiency is among the most prevalent and persistent findings in pediatric post-concussion syndrome, often responding to targeted vision therapy. NPC measurement is rapid and highly sensitive.
VOR
Vestibulo-Ocular Reflex Gain in Acute mTBI
VOR gain reduction precedes all subjective symptom reporting and is detectable in the acute period. The 3-neuron VOR arc — the shortest in the CNS — is exquisitely sensitive to disruption at the vestibular nuclei, MLF, and ocular motor cranial nerve level.
Pupillometry
Automated Pupillometry in TBI Assessment
Pupil light reflex latency and constriction velocity quantify afferent pathway function. The Neurological Pupil index (NPi) and RAPD assessment provide rapid, non-invasive markers of cranial nerve III and pretectal involvement detectable before structural imaging changes.
Sex Differences
Female-Specific Outcomes in Pediatric Concussion
Female patients consistently demonstrate higher symptom burden, longer recovery, and greater PCS rates than males sustaining equivalent injuries. Proposed mechanisms include cervical muscle differences, hormonal modulation of neuroinflammation, and baseline neurological architecture differences. Normative databases must be sex-stratified.

Get in Touch

Request Device Information,
Clinical Data, or Pilot Enrollment

ClearGazeTest was developed by Dr. Michael Duplessie (M.B., B.Ch., B.A.O., L.R.C.P.&S.I.) — a physician-surgeon who organized the first US LASIK course, pioneered modern lamellar corneal transplantation, and most recently founded Medical Card Exam™ (30,000+ patients) and the ANCHOR™ national outcomes initiative. We are actively seeking clinical pilot partners, IRB co-investigators, and early-adopter practices. Device demonstrations available by request.

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Clinical Pilot Program
Join our IRB-approved normative database study. Pilot practices receive devices at cost and co-author the first peer-reviewed publication.
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CPT & Billing Consultation
Our reimbursement team can provide payer-specific guidance and pre-authorization support for your practice or institution.
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Research Collaboration
We welcome academic collaboration proposals. Data-sharing agreements and grant co-PI arrangements available for qualified institutions.
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Related Resources
KidConcussion.com — patient & family resource site
ClearGazeTest.com — technology & investor site