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

NCT07141719 | Not Yet Recruiting

• 1 other identifier: D 481/25
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Geriatric; Parkinsons Disease (PD); Progressive Supranuclear Palsy(PSP); Neurological Diseases or Conditions

Outcome Measures

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.

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

Secondary Outcomes (12)

• Vestibulo-ocular reflex (VOR)

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

• Vestibulo-ocular reflex suppression (VORS)

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

• Saccades velocity

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

• Glabella reflex

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

• Pupillary reflex

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

Study Arms (1)

Persons with neurological conditions

Patients admitted to the wards and the outpatient clinics of the Department of Neurology, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kiel: lead

Study Sites (1)

Department of Neurology

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Parkinson Disease; Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Walter Maetzler, Prof.

CONTACT

004943123981; w.maetzler@neurologie.uni-kiel.de

Patrik Theodor Nerdal, Dr.

CONTACT

004943123939; T.Nerdal@googlemail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Walter Maetzler

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 26, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)