Eye Tracking Technology in the Diagnosis of Neurological Patients

Traumatic Brain Injury Clinical Trial

Official title:

Evaluating the Use of Eye-tracking Technology in the Diagnosis of Neurological Patients, Including Patients With Reduced Consciousness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05536921
• Other study ID #: C-EYE_DIAGNOSIS_X001
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2023
• Source: AssisTech Sp. z o.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 practice (like behavioural scales on paper forms).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Completed 18 years of age.

2. Consent of the legal guardian to participate in the Study and access to medical records.

3. Medical diagnosis indicating damage to the central nervous system.

4. Having and sharing a description of imaging tests (alternatively MRI - Magnetic Resonance Imaging or CT - Computed Tomography) and (alternatively) ophthalmoscopy, ophthalmology, auditory tests.

5. Presentation of a list of medications used by the patient that may affect the results obtained in tests of cognitive function.

6. 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:

1. the ability to communicate only by sight (no verbal, sign or other communication),

2. the absence of dementia and aphasic disorders before the event that led to CNS damage and the patient's current condition,

3. preserved at least one functioning eyeball (possibility of cooperation with an eye tracker).

Exclusion Criteria:

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

2. 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).

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Dysfunction
• Consciousness Disorders
• Diagnosis
• Disease
• Disorder of Consciousness
• Minimally Conscious State
• Nervous System Diseases
• Neurological Disease
• Neurological Injury
• Persistent Vegetative State
• Trauma, Nervous System
• Traumatic Brain Injury
• Vegetative State
• Wounds and Injuries

Locations

Country	Name	City	State
Poland	Care and Rehabilitation Center "HEALTH" ("ZDROWIE")	Czestochowa
Poland	Polish Center for Functional Rehabilitation VOTUM	Kraków
Poland	Polish Center for Functional Rehabilitation SAWIMED	Sawice
Poland	Neurorehabilitation Center of Dr. Roman Olejniczak	Wroclaw
Poland	County Hospital	Zawiercie

Sponsors (1)

Lead Sponsor	Collaborator
AssisTech Sp. z o.o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 +	14 days
Primary	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%	14 days

External Links

•   Sponsor's website