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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).
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Test 1: Minimally Conscious State Detection (MCSD Test) | The Test 1 consist of 6 subscales (including 11 points):
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:
| 14 days |
| Test 2: Cognitive Function Assessment (CFA Test) | The Test 2 consist of 6 subscales (including 24 points):
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 result obtained:
| 14 days |
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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:
Exclusion Criteria:
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Neurological patients after brain injury with communication barriers, diagnosed as unresponsive wakefulness syndrome (UWS) or minimal consciousness state (MCS) patients.
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| Name | Affiliation | Role |
|---|---|---|
| Grzegorz Żurek, Prof. | Wroclaw University of Health and Sport Sciences | Principal Investigator |
| Bartosz Kunka, Ph.D. | AssisTech Sp. z o.o. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care and Rehabilitation Center "HEALTH" ("ZDROWIE") | Częstochowa | 42-207 | Poland | |||
| Polish Center for Functional Rehabilitation VOTUM |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41419503 | Derived | 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. |
| Label | URL |
|---|---|
| Sponsor's website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Aug 25, 2022 |
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| Krakow |
| 30-723 |
| Poland |
| Polish Center for Functional Rehabilitation SAWIMED | Sawice | 08-307 | Poland |
| Neurorehabilitation Center of Dr. Roman Olejniczak | Wroclaw | 54-530 | Poland |
| County Hospital | Zawiercie | 42-400 | Poland |
| Sep 8, 2022 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D018458 | Persistent Vegetative State |
| D003244 | Consciousness Disorders |
| D020207 | Coma, Post-Head Injury |
| D020196 | Trauma, Nervous System |
| D000070642 | Brain Injuries, Traumatic |
| D004194 | Disease |
| D060825 | Cognitive Dysfunction |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
| D000860 | Hypoxia |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014474 | Unconsciousness |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006259 | Craniocerebral Trauma |
| D010335 | Pathologic Processes |
| D003072 | Cognition Disorders |
| D012818 | Signs and Symptoms, Respiratory |
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