GeriatricNEX-EyeNCT07141719
Collection of Digital Parameters From Parts of the Neurological Examination Using an Eye Tracker
An observational study of Geriatric and Parkinsons Disease (PD), run by University of Kiel at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Geriatric, Parkinsons Disease (PD), Progressive Supranuclear Palsy(PSP)
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- 31 Aug 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult volunteers hospitalized on the wards and outpatient areas of the Department of Neurology
Who may be able to join
- ≥ 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Department of Neurology
Kiel, Schleswig-Holstein, 24105
Patrik Theodor Nerdal, Dr., 004943150023939, T.Nerdal@googlemail.com
About this study
Official title: A Digital Protocol for Neurological Examination Using Eye-Tracking
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.
Read more
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
- Medical subject headings
- Parkinson Disease, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Persons with neurological conditions | Patients admitted to the wards and the outpatient clinics of the Department of Neurology, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (single session, approx. 2-3 hour per participant)
Secondary outcomes (12)
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.
Measured: Baseline (single session, approx. 2-3 hour per participant)
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.
Measured: Baseline (single session, approx. 2-3 hour per participant)
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.
Measured: Baseline (single session, approx. 2-3 hour per participant)
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.
Measured: Baseline (single session, approx. 2-3 hour per participant)
Pupillary reflex
The pupillary light reflex is assessed by alternately illuminating each eye. An eye-tracker records pupil size, shape, latency, and constriction velocity. Asymmetric responses may indicate neurological deficits. Differences between eyes are quantified, with thresholds based on clinical norms.
Measured: Baseline (single session, approx. 2-3 hour per participant)
Pupil size at rest
Resting pupil size is measured and compared to normative thresholds. Values outside defined ranges are classified as mydriasis (dilated), miosis (constricted), or normal.
Measured: Baseline (single session, approx. 2-3 hour per participant)
Nystagmus at rest, slow phase
Nystagmus is characterized by alternating slow and fast eye movements. At rest, the slow phase velocity (°/s) is recorded during gaze to the left and right using the eye-tracker.
Measured: Baseline (single session, approx. 2-3 hour per participant)
Skew deviation
Skew deviation is assessed using alternate eye cover testing while the participant fixates on a target. A positive result is indicated by vertical correction movements (geotropic/apogeotropic). The presence and magnitude of deviation are evaluated based on predefined thresholds.
Measured: Baseline (single session, approx. 2-3 hour per participant)
Smooth pursuit (SP) number of saccades
Smooth pursuit (SP) is an eye movement in which a moving object is tracked by the eyes without moving the head. The tracking can be saccadic, i.e. jerky, or significantly impaired or incomplete in certain directions, such as upwards. Here, too, the investigators digitally record the extent of the eye movement during neurological examination.
A disturbance of the SP is indicated by the presence of correction Saccades, which are recorded digitally. As the corrective saccade is a physiological process, the saccade is preceded by a slow phase. During this slow phase, the eye The frequency of the saccades in a time unit is indicated and, if possible, the nature and amplitude. Threshold values for this result from a comparison with the clinical examination and the gestural impression.
The investigators measure the number of correction saccades per second as a measure of ability to maintain smooth pursuit.
Measured: Baseline (single session, approx. 2-3 hour per participant)
Smooth pursuit (SP) saccade amplitude
The amplitude of the correction saccades, for example in °, during smooth pursuit (SP) also provides information about how saccades can be performed. Together with the number of saccades, it can provide information about the role that the ability to initiate and perform saccades plays during SP. Saccades may play a different role during SP than during gaze shifts.
The mean amplitude of the saccades is determined.
Measured: Baseline (single session, approx. 2-3 hour per participant)
Smooth pursuit (SP) slow phase velocity
The saccades during smooth pursuit (SP) are preceded by a slow phase, the speed of which can be determined. The investigators calculate the mean of all slow phases in °/s.
Measured: Baseline (single session, approx. 2-3 hour per participant)
Nystagmus at rest, quick phase
Nystagmus is characterized by alternating slow and fast eye movements. The fast phase is expressed as a saccade, which is recorded and measured in degree.
Measured: Baseline (single session, approx. 2-3 hour per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start31 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kiel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter Maetzler, University of Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141719
- Sponsor's protocol ID
- D 481/25
- Acronym
- NEX-Eye
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Protocol for Neurological Examination Using Eye-Tracking
- ClinicalTrials.gov ID
- NCT07141719
- Acronym / sponsor ID
- NEX-Eye / D 481/25
- Conditions
- Geriatric, Parkinsons Disease (PD), Progressive Supranuclear Palsy(PSP), Neurological Diseases or Conditions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of KielUniversity, hospital or other
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with neurological conditions | – | –Patients admitted to the wards and the outpatient clinics of the Department of Neurology, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult volunteers hospitalized on the wards and outpatient areas of the Department of Neurology
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
System Usability Scale (SUS)
Time frame: Baseline (single session, approx. 2-3 hour per participant)
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.
12 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric and Parkinsons Disease (PD), run by University of Kiel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walter Maetzler, Prof. (004943123981, w.maetzler@neurologie.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) (time frame: Baseline (single session, approx. 2-3 hour per participant)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.