Collection of Digital Parameters From Parts of the Neurological Examination Using an Eye Tracker

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Kiel

About this trial

The neurological examination (NE) is a cornerstone of clinical neurology, with ocular motor assessment being a key component. Technology offers an opportunity to augment and standardize parts of the NE. Eye-tracking systems provide objective quantitative data on eye movements by continuously tracking the eye over time. This data can be used to derive parameters like saccadic latency, gaze velocity, and fixation stability with a precision that is impossible to achieve through human observation by neurologists. The integration of such technology could enhance the traditional NE.

Before such technology can be widely adopted, its feasibility and acceptability in a clinical population must be established. The primary purpose of this study is to assess the usability of a novel eye-tracking system from the patient's perspective when used in a clinical settings. A secondary purpose is to determine if quantitative data from the eye-tracker correlate with the findings of the traditional clinical neurological examination and to explore whether eye-tracking can provide additional, complementary information not typically captured by standard clinical assessment.

To achieve these aims, the study will assess several outcome measures. The primary outcome measure is the Usability of the Eye-Tracking System, which will be measured using the System Usability Scale (SUS).

Beyond the primary objectives, this study will investigate two secondary objectives.

The first involves assessing the relationship between quantitative eye-tracking parameters and clinical ocular motor assessment. Specifically, the investigators will analyze objective, numerical data obtained from eye-tracking systems and the clinician's subjectively graded assessment of ocular movements derived from the standard neurological examination.

The second is the exploratory analysis of novel eye-tracking biomarkers. This involves quantifying and analyzing eye-tracking parameters not typically assessed during a routine NE. For example, the dynamics of the pupillary light reflex or the frequency of microsaccades. The aim is to identify potential digital biomarkers that could provide additional objective insights into ocular motor function and neurological status.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years of age.

Diagnosed or treated for a neurological disease.

Hospitalized or outpatient of the Department of Neurology, UKSH Campus Kiel.

Ability of the person to understand oral study information and study information sheet, and willingness to provide a signed and dated informed consent form.

Disqualifiers

Being under legal guardianship

Impaired decision-making capacity, or temporal or spatial disorientation which may be revealed within ordinary conversation or by a confirmed diagnosis of dementia. In case of doubt, the Montreal Cognitive Assessment (MoCA, pass cutoff score > 18 16) will be administered.

Trial population

Adult volunteers hospitalized on the wards and outpatient areas of the Department of Neurology

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Persons with neurological conditions

Trial outcomes

Primary outcomes

1

System Usability Scale (SUS)

The System Usability Scale (SUS) is a validated and widely used 10-item questionnaire designed to assess the subjective usability of a system-in this case, a wearable eye-tracking device. Each item is rated on a 5-point Likert scale from Strongly Disagree (1) to Strongly Agree (5). The SUS yields a single score ranging from 0 to 100, where higher scores indicate greater perceived usability. A score of 68 is generally considered average; scores above 80 indicate high usability, while scores below 50 suggest usability concerns. Usability, in this context, includes perceptions of comfort, system complexity, ease of use, learnability, and willingness to use the system regularly or independently. Participants complete the SUS immediately after using the eye-tracker in a controlled session.

Time frame
Baseline (single session, approx. 2-3 hour per participant)

Secondary outcomes

1

Vestibulo-ocular reflex (VOR)

The vestibulo-ocular reflex (VOR) is measured using the eye-tracker during sitting, standing, and walking. Participants' heads are passively rotated at 100-300 °/s, and the ratio of eye velocity to head velocity (velocity gain) is calculated. A gain of 1.0 indicates perfect VOR function; 0 indicates complete absence.

Time frame
Baseline (single session, approx. 2-3 hour per participant)
2

Vestibulo-ocular reflex suppression (VORS)

Vestibulo-ocular reflex suppression (VORS) is assessed using a head-fixed target. Reflexive eye drift opposite to head movement is measured in sitting, standing, and walking. VORS is calculated as the ratio of eye position to head position (position gain). A score of 100% indicates full expression of the vestibuloocular reflex (VOR) (no suppression), while 0% indicates complete suppression.

Time frame
Baseline (single session, approx. 2-3 hour per participant)
3

Saccades velocity

Saccades are rapid eye movements used to fixate on new visual targets. Using the eye-tracker, saccade velocity (°/s) is recorded and analyzed to detect abnormalities such as slowed or dysmetric movements.

Time frame
Baseline (single session, approx. 2-3 hour per participant)
4

Glabella reflex

The glabellar reflex is assessed by repeated tapping of the participant's glabella. Normally, the blink response habituates after 3-5 taps. Persistent blinking beyond this suggests reduced frontal lobe inhibition. The total number of blinks is recorded.

Time frame
Baseline (single session, approx. 2-3 hour per participant)

Other outcomes

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