Eye Tracking Technology in the Diagnosis of Neurological Patients

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

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).

Study Overview

• Status: Completed
• Conditions: Cognitive Dysfunction; Traumatic Brain Injury; Disorder of Consciousness; Minimally Conscious State; Diagnosis; Neurological Injury; Vegetative State; Neurological Disease; Postcomatose Unawareness State; Post-Traumatic Coma

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Poland
  • Częstochowa, Poland, 42-207
    • Care and Rehabilitation Center "HEALTH" ("ZDROWIE")
  • Kraków, Poland, 30-723
    • Polish Center for Functional Rehabilitation VOTUM
  • Sawice, Poland, 08-307
    • Polish Center for Functional Rehabilitation SAWIMED
  • Wrocław, Poland, 54-530
    • Neurorehabilitation Center of Dr. Roman Olejniczak
  • Zawiercie, Poland, 42-400
    • County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test 1: Minimally Conscious State Detection (MCSD Test)	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 +	14 days
Test 2: Cognitive Function Assessment (CFA Test)	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%	14 days

Collaborators and Investigators

• Sponsor: AssisTech Sp. z o.o.
• Investigators: Principal Investigator: Grzegorz Żurek, Prof., Wroclaw University of Health and Sport Sciences; Study Chair: Bartosz Kunka, Ph.D., AssisTech Sp. z o.o.

Publications and helpful links

Helpful Links

• Sponsor's website

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: trauma; Hypoxia; brain injury; diagnostic test; Coma; cognitive assessment; eye tracking; Cognitive Functions Assessment (CFA); reduced consciousness; Unresponsive Wakefulness Syndrome (UWS); Minimally Conscious State Detection (MCSD); coma recovery
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Brain Damage, Chronic; Craniocerebral Trauma; Cognition Disorders; Unconsciousness; Coma; Disease; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Nervous System Diseases; Cognitive Dysfunction; Consciousness Disorders; Trauma, Nervous System; Persistent Vegetative State; Coma, Post-Head Injury
• Other Study ID Numbers: C-EYE_DIAGNOSIS_X001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No