Eye Tracking Technology in the Diagnosis of Neurological Patients

Demonstrating that diagnostics of the state of consciousness and cognitive functions of patients with consciousness disorders performed using C-Eye X (based on eye-tracking technology) allows a more objective assessment of state of patients who were wrongly diagnosed based on popular methods using in a clinical practice (like behavioural scales on paper forms).

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Key information

Conditions

Postcomatose Unawareness State Brain Damage, Chronic Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Coma Coma, Post-Head Injury Consciousness Disorders Craniocerebral Trauma Diagnosis Disease Disorder of Consciousness Hypoxia Mental Disorders Minimally Conscious State Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Neurological Disease Neurological Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Vegetative State Post-Traumatic Coma Signs and Symptoms Signs and Symptoms, Respiratory Trauma, Nervous System Traumatic Brain Injury Unconsciousness Vegetative State Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Care and Rehabilitation Center "HEALTH" ("ZDROWIE"), Częstochowa, Poland

About this study

The aim of this Study is to perform a clinical evaluation of the authors' original battery of diagnostic tests in the C-Eye X system (based on eye-tracking technology), addressed to patients who have suffered damage to the central nervous system (CNS) with communication barriers. Validation is being conducting for 2 original diagnostic tests: MCSD (Minimally Conscious State Detection): to differentiate patients' state of consciousness (for patients diagnosed as being in unresponsive wakefulness syndrome (UWS) or minimally consciousness state (MCS) and CFA (Cognitive Functions Assessment) to assess the level of preserved cognitive functions in patients (for patients diagnosed as being in at least minimally consciousness state minus (MCS-). The intention of the project's authors is to introduce a novel diagnostic solution that will help reduce misdiagnoses made for neurological patients with reduced consciousness, due to the inadequacy of current behavioural tools to work with patients after severe brain damage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Completed 18 years of age.
Consent of the legal guardian to participate in the Study and access to medical records.
Medical diagnosis indicating damage to the central nervous system.
Having and sharing a description of imaging tests (alternatively MRI - Magnetic Resonance Imaging or CT - Computed Tomography) and (alternatively) ophthalmoscopy, ophthalmology, auditory tests.
Presentation of a list of medications used by the patient that may affect the results obtained in tests of cognitive function.
Acceptance by a physician (e.g. neurologist, neurosurgeon, internist) to participate in a clinical trial, taken after reviewing the Study protocol, including there is a need to take into account:

the ability to communicate only by sight (no verbal, sign or other communication),
the absence of dementia and aphasic disorders before the event that led to CNS damage and the patient's current condition,
preserved at least one functioning eyeball (possibility of cooperation with an eye tracker).

Exclusion criteria

Visual defect (refractive defect) diagnosed before the incident, requiring work with glasses with lenses of more than ±3 diopters.
Inclusion of drug treatment during the Study (observation), which can affect the patient's cognitive functioning (both in terms of cognitive enhancement and impairment/dementia).

Treatment and study plan

Primary outcomes

Test 1: Minimally Conscious State Detection (MCSD Test)

Time frame: 14 days
The Test 1 consist of 6 subscales (including 11 points):
- Auditory sensitivity
- Visual functions
- Auditory-visual integration
- Command execution
- Autopsychic orientation
- Pressure localisation test
The MCSD Test is performed in 5 trials during 14 days of observation with intervals of at least one day between test repetitions.

The result of the completed test is an indicator of one of the following states of the patient's condition diagnosis:
- UWS
- MCS -
- MCS +
Test 2: Cognitive Function Assessment (CFA Test)

Time frame: 14 days
The Test 2 consist of 6 subscales (including 24 points):
- Attention
- Language functions
- Visual-spatial functions
- Autopsychic orientation
- Memory
- Abstract thinking
The total number of points that a patient can obtain in a single trial for performing tasks in the CFA test is 24 points. The CFA Test is performed in 3 trials during 14 days at intervals of at least one day.

For the CFA test, the results will be presented as:
- the sum of scores for all subscales of the test,
- the point value obtained in each subscale,
- the percentage of the total score for all subscales of the test related to the maximum value possible for the test - 24 points
- the percentage value in each subscale related to the maximum value possible in the subscale.
The result obtained:
- ______ - ____%
- ______ - ____%
- ______ - ____% Total score = ____% Scale: 0 - 100%

Sponsors and collaborators

Lead sponsor

AssisTech Sp. z o.o.

Industry

Registry information

Official study title

Evaluating the Use of Eye-tracking Technology in the Diagnosis of Neurological Patients, Including Patients With Reduced Consciousness

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Sep 13, 2022
Registry last updated: Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed