CompletedNot Applicable

Eye Tracking Technology in the Diagnosis of Neurological Patients

Poland90 participantsStarted 2022-05-01

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

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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:
✓. 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,

Exclusion criteria

✕. 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).

What they're measuring

Test 1: Minimally Conscious State Detection (MCSD Test)

Timeframe: 14 days

Test 2: Cognitive Function Assessment (CFA Test)

Timeframe: 14 days

Trial details

NCT IDNCT05536921

SponsorAssisTech Sp. z o.o.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-01-31

View on ClinicalTrials.gov More Postcomatose Unawareness State trials