Clinical trial NCT05536921: Eye Tracking Technology in the Diagnosis of Neurological Patients
Official title: Evaluating the Use of Eye-tracking Technology in the Diagnosis of Neurological Patients, Including Patients With Reduced Consciousness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postcomatose Unawareness State
Minimally Conscious State
Vegetative State
Disorder of Consciousness
Post-Traumatic Coma
Neurological Injury
Traumatic Brain Injury
Diagnosis
Cognitive Dysfunction
Neurological Disease
Keywords: Coma
Hypoxia
Cognitive Functions Assessment (CFA)
trauma
cognitive assessment
diagnostic test
reduced consciousness
eye tracking
Unresponsive Wakefulness Syndrome (UWS)
Minimally Conscious State Detection (MCSD)
brain injury
coma recovery
Lead sponsor: AssisTech Sp. z o.o.
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neurological patients after brain injury with communication barriers, diagnosed as unresponsive wakefulness syndrome (UWS) or minimal consciousness state (MCS) patients.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Completed 18 years of age.
2. Consent of the legal guardian to participate in the Study and access to medical records.
3. Medical diagnosis indicating damage to the central nervous system.
4. Having and sharing a description of imaging tests (alternatively MRI - Magnetic Resonance Imaging or CT - Computed Tomography) and (alternatively) ophthalmoscopy, ophthalmology, auditory tests.
5. Presentation of a list of medications used by the patient that may affect the results obtained in tests of cognitive function.
6. 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:

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

Exclusion Criteria:

1. Visual defect (refractive defect) diagnosed before the incident, requiring work with glasses with lenses of more than ±3 diopters.
2. 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).

Primary outcomes:
measure: Test 1: Minimally Conscious State Detection (MCSD Test)
timeFrame: 14 days
measure: Test 2: Cognitive Function Assessment (CFA Test)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Częstochowa
country: Poland
facility: Care and Rehabilitation Center "HEALTH" ("ZDROWIE")
city: Kraków
country: Poland
facility: Polish Center for Functional Rehabilitation VOTUM
city: Sawice
country: Poland
facility: Polish Center for Functional Rehabilitation SAWIMED
city: Wrocław
country: Poland
facility: Neurorehabilitation Center of Dr. Roman Olejniczak
city: Zawiercie
country: Poland
facility: County Hospital
Study officials:
affiliation: Wroclaw University of Health and Sport Sciences
name: Grzegorz Żurek, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: AssisTech Sp. z o.o.
name: Bartosz Kunka, Ph.D.
role: STUDY_CHAIR
References: