Collection of Digital Parameters From Parts of the Neurological Examination Using an Eye Tracker
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Geriatric, Parkinsons Disease (PD), Progressive Supranuclear Palsy(PSP), Neurological Diseases or Conditions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Digital Protocol for Neurological Examination Using Eye-Tracking
Overview
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.
Primary outcome measures
- System Usability Scale (SUS) [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
Secondary outcome measures (12)
- Vestibulo-ocular reflex (VOR) [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Vestibulo-ocular reflex suppression (VORS) [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Saccades velocity [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Glabella reflex [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Pupillary reflex [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Pupil size at rest [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Nystagmus at rest, slow phase [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Skew deviation [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Smooth pursuit (SP) number of saccades [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Smooth pursuit (SP) saccade amplitude [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Smooth pursuit (SP) slow phase velocity [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
- Nystagmus at rest, quick phase [Time frame: Baseline (single session, approx. 2-3 hour per participant)]
Eligibility criteria
Inclusion criteria
- ≥ 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Germany · 1 center
- Department of Neurology — Kiel
Identifiers
NCT: NCT07141719 · D 481/25