An observational study in Postcomatose Unawareness State, Minimally Conscious State and Vegetative State, sponsored by AssisTech Sp. z o.o.. Completed at 5 sites in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by AssisTech Sp. z o.o. · Observational
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.
88 studies on the registry are indexed under Persistent Vegetative State; 20 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 31 observational studies indexed under Persistent Vegetative State.
Browse Persistent Vegetative State studies →This is the only study on the registry with AssisTech Sp. z o.o. as lead sponsor.
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Neurological patients after brain injury with communication barriers, diagnosed as unresponsive wakefulness syndrome (UWS) or minimal consciousness state (MCS) patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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 +
Time frame: 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%
Time frame: 14 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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