Postcomatose Unawareness StateNCT05536921
Eye Tracking Technology in the Diagnosis of Neurological Patients
An observational study of Postcomatose Unawareness State and Minimally Conscious State, run by AssisTech Sp. z o.o. at 5 sites in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postcomatose Unawareness State, Minimally Conscious State, Vegetative State
- How many people
- 90 participants
- Where
- 5 sitesPoland
- Study dates
- 1 May 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neurological patients after brain injury with communication barriers, diagnosed as unresponsive wakefulness syndrome (UWS) or minimal consciousness state (MCS) patients.
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
Care and Rehabilitation Center "HEALTH" ("ZDROWIE")
Częstochowa, 42-207
Polish Center for Functional Rehabilitation VOTUM
Krakow, 30-723
Polish Center for Functional Rehabilitation SAWIMED
Sawice, 08-307
Neurorehabilitation Center of Dr. Roman Olejniczak
Wroclaw, 54-530
County Hospital
Zawiercie, 42-400
About this study
Official title: 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).
Read the 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.
- Conditions
- Postcomatose Unawareness State, Minimally Conscious State, Vegetative State, Disorder of Consciousness, Post-Traumatic Coma, Neurological Injury
- 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
- Medical subject headings
- Persistent Vegetative State, Consciousness Disorders, Coma, Post-Head Injury, Trauma, Nervous System, Brain Injuries, Traumatic, Disease, Cognitive Dysfunction, Nervous System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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 +
Measured: 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%
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 May 2022
- Primary completion31 Jan 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postcomatose Unawareness StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- AssisTech Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grzegorz Żurek, Prof., Principal investigator, Wroclaw University of Health and Sport SciencesBartosz Kunka, Ph.D., Study chair, AssisTech Sp. z o.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536921
- Sponsor's protocol ID
- C-EYE_DIAGNOSIS_X001
- Status last verified
- Jul 2023
- First submitted
- 8 Sep 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41419503
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Eye-tracking Technology in the Diagnosis of Neurological Patients, Including Patients With Reduced Consciousness
- ClinicalTrials.gov ID
- NCT05536921
- Acronym / sponsor ID
- C-EYE_DIAGNOSIS_X001
- Conditions
- Postcomatose Unawareness State, Minimally Conscious State, Vegetative State, Disorder of Consciousness, Post-Traumatic Coma, Neurological Injury
- Keywords
- Coma, Hypoxia, Cognitive Functions Assessment (CFA), trauma, cognitive assessment, diagnostic test, reduced consciousness, eye tracking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AssisTech Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurological patients after brain injury with communication barriers, diagnosed as unresponsive wakefulness syndrome (UWS) or minimal consciousness state (MCS) patients.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test 1: Minimally Conscious State Detection (MCSD Test)
Time frame: 14 days
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 +
Test 2: Cognitive Function Assessment (CFA Test)
Time frame: 14 days
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 41419503Grzegorz 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.
- Sponsor's websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grzegorz Żurek, Prof. principal investigator
Wroclaw University of Health and Sport Sciences
Bartosz Kunka, Ph.D. study chair
AssisTech Sp. z o.o.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postcomatose Unawareness State and Minimally Conscious State, run by AssisTech Sp. z o.o. at 5 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test 1: Minimally Conscious State Detection (MCSD Test) (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05536921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.