ClinicalTrials.gov record NCT07141719
Collection of Digital Parameters From Parts of the Neurological Examination Using an Eye Tracker
A Digital Protocol for Neurological Examination Using Eye-Tracking
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study asks adults with neurological diseases (for example, Parkinsons disease or PSP) who are seen as inpatients or outpatients in neurology to try an eye-tracking system in a single visit. Participants will perform brief eye- and movement-related tasks while wearing the device, and then complete a usability questionnaire (System Usability Scale). The study also collects quantitative eye-movement data to compare with the clinician's neurological exam.
What it is studying. The study is testing the usability of a wearable eye-tracking system from the patient’s perspective using the System Usability Scale. It is also testing whether quantitative eye-tracking measures (for example saccade speed, pupillary reflex metrics, vestibulo-ocular reflex measures, nystagmus, and smooth pursuit parameters) relate to the findings of the standard clinical neurological eye-movement exam, and exploring novel digital eye-tracking biomarkers not typically measured in routine exams.
What the researchers hope to learn. To measure how usable patients find the eye-tracking system; to determine whether eye-tracking measurements correlate with standard clinical ocular-motor exam findings; and to explore candidate digital biomarkers (for example pupillary dynamics or microsaccade measures) that could add objective information about eye-movement function.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Take part in a single controlled session (about 2–3 hours) using a wearable eye-tracking device while sitting, standing, and walking. Tasks include looking at visual targets, tests of eye movements (saccades, smooth pursuit), pupillary light tests (flashing light into each eye), glabella tapping (repeated forehead taps to record blink response), and passive head rotations to measure vestibular eye reflexes. The study team records digital eye-movement data and asks participants to complete a short usability questionnaire (the System Usability Scale) immediately after the session. If cognitive ability is unclear, a brief cognitive test (MoCA) may be administered.
How the study is structured. Observational, cross-sectional study. Each participant takes part in a single session (about 2–3 hours) during which they wear an eye-tracker while clinicians perform standard ocular-motor assessments and while participants perform tasks in sitting, standing, and walking positions as appropriate. Participants complete the System Usability Scale immediately after using the device. No experimental treatment is assigned.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in Germany. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on progressive supranuclear palsy
Important dates
- Study start
- Aug 31, 2025 (estimated)
- Primary completion
- Dec 31, 2026 (estimated)
- Study completion
- Dec 31, 2026 (estimated)
- Target enrollment
- 600 participants (estimated)
- Last updated on registry
- Aug 26, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University of Kiel
- Principal investigator
- Walter Maetzler, Prof. Dr. med. Walter Maetzler
University of Kiel
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Walter Maetzler, Prof. 📞 004943123981 ✉ w.maetzler@neurologie.uni-kiel.de
- Patrik Theodor Nerdal, Dr. 📞 004943123939 ✉ T.Nerdal@googlemail.com
Participating sites (1)
- Department of Neurology
Kiel, Schleswig-Holstein, 24105 · Germany
- Patrik Theodor Nerdal, Dr. · 004943150023939 · T.Nerdal@googlemail.com
Terms used on this page · explanations by MedicalUpdates.ai
- primary purpose
- The main reason an interventional study is being done, for example treatment, prevention, diagnosis, supportive care or basic science.
- outcome measures
- Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
- primary outcome measure
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- biomarkers
- Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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