Eye Tracking Technology in the Diagnosis of Neurological Patients

NCT05536921 | Completed

• 1 other identifier: C-EYE_DIAGNOSIS_X001
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 5

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).

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

Outcome Measures

Primary Outcomes (2)

• Test 1: Minimally Conscious State Detection (MCSD Test)

  The Test 1 consist of 6 subscales (including 11 points): 1. Auditory sensitivity 2. Visual functions 3. Auditory-visual integration 4. Command execution 5. Autopsychic orientation 6. 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): 1. Attention 2. Language functions 3. Visual-spatial functions 4. Autopsychic orientation 5. Memory 6. 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: 1. the sum of scores for all subscales of the test, 2. the point value obtained in each subscale, 3. the percentage of the total score for all subscales of the test related to the maximum value possible for the test - 24 points 4. the percentage value in each subscale related to the maximum value possible in the subscale. The result obtained: 1. \_\_\_\_\_\_ - \_\_\_\_% 2. \_\_\_\_\_\_ - \_\_\_\_% 3. \_\_\_\_\_\_ - \_\_\_\_% Total score = \_\_\_\_% Scale: 0 - 100%

  14 days

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• AssisTech Sp. z o.o.: lead

Study Sites (5)

Care and Rehabilitation Center "HEALTH" ("ZDROWIE")

Częstochowa, 42-207, Poland

Location

Polish Center for Functional Rehabilitation VOTUM

Krakow, 30-723, Poland

Location

Polish Center for Functional Rehabilitation SAWIMED

Sawice, 08-307, Poland

Location

Neurorehabilitation Center of Dr. Roman Olejniczak

Wroclaw, 54-530, Poland

Location

County Hospital

Zawiercie, 42-400, Poland

Location

Related Publications (1)

• Grzegorz Z, Karolina KN, Bartosz K, Marek B. Eye tracking as a novel approach to cognitive assessment in DOC patients based on evidence from a multicenter clinical trial. Sci Rep. 2025 Dec 19;15(1):44205. doi: 10.1038/s41598-025-27996-6.

  PMID: 41419503 DERIVED

Related Links

• Sponsor's website

MeSH Terms

Conditions

Persistent Vegetative State; Consciousness Disorders; Coma, Post-Head Injury; Trauma, Nervous System; Brain Injuries, Traumatic; Disease; Cognitive Dysfunction; Nervous System Diseases; Coma; Hypoxia; Wounds and Injuries; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Craniocerebral Trauma; Pathologic Processes; Cognition Disorders; Signs and Symptoms, Respiratory

Study Officials

• Grzegorz Żurek, Prof.

  Wroclaw University of Health and Sport Sciences

  PRINCIPAL INVESTIGATOR

• Bartosz Kunka, Ph.D.

  AssisTech Sp. z o.o.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: May 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5)