Clinical trial NCT05784623: Interest and Feasibility of the DIGItracking Technique for the Early Diagnosis of COGnitive Disorders
Official title: DIGICOG-start: Intérêt et faisabilité de la Technique de DIGItracking Pour Diagnostiquer précocement Les Troubles de la COGnition au Cours de la Vie
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: digit-tracking
elderly
neurocognitive disorders
usability
user experience
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-03-27
Enrollment: 135
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients meeting the eligibility criteria over the study period.

Brief summary: The main objective is to assess the usability of a novel tool of neurocognitive disorders detection, called the Digitracking, by the elderly population. The Digitracking technique is based on the eye tracking concept to assess cognitive decline (Lio et al. 2019). Instead of capturing eye movements, the new device captures the finger trajectory while exploring a blurred picture on a tablet. The usability of such a technology is assessed through objective and subjective metrics, such as the user experience.

Detailed description: Methods for cognitive decline diagnosis in elderly patients using simple, fun and ecological tests remain a major health issue. The objective is the early diagnosis of disorders in order to offer quick management of the decline of cognitive functions.

Eye tracking is a proven technique to study perceptual and cognitive functions in children and adults. It has recently been highlighted that it was also relevant to analyze the perceptual and cognitive functions of elderly people at different stages of neurocognitive disorders. Although very precise, this technique remains restrictive since it requires expensive equipment, technical skills, and long and repetitive tests while the patient stays motionless.

A new approach using the digit-tracking, named Digitrack (Lio et al. 2019), has shown excellent correlation with the eye tracking. The general principle is as follows: a blurred image is displayed on a touchpad screen. This degraded image reproduces the spatial resolution of the peripheral retina. While the patient put his finger on the screen, the area around the finger is unblurred, simulating the foveal region (central region) of the eye. By sliding his finger, the subject moves the unblurred window and can explore the image. The exploration trajectory, like the eye movement trajectory with eye tracking, is recorded and reveals the subjective regions of interest contained in the image which help to assess the user's neurocognitive functions.

The advantage of the Digitrack process is to require a cheap and easy-to-use device to assess the cognitive status of patients in a fun way and close to real conditions.

To date, its usability has not been demonstrated in elderly patients with or without neurocognitive disorders.

The investigators formulate the main hypothesis that patients visiting or hospitalized in the acute care geriatrics department, with or without cognitive disorders, can use the Digitrack process.

Eligibility criteria: Inclusion Criteria:

* Men or women ≥ 75 years old
* Consultation or hospitalization in geriatrics department
* Subjects who can give written consent to participate in the study

Exclusion Criteria:

* Photosensitive epilepsy
* Uncorrected visual deficiency
* Any significative impairment at the upper limb level preventing from manipulating the device
* Persons deprived of their liberty by administrative or judicial decision, persons under psychiatric care under duress, adults subject to a legal protection measure or unable to express their consent

Primary outcomes:
measure: Success rate of the Digitrack use
timeFrame: after 5 minutes of Digitrack use
Secondary outcomes:
measure: User experience assessed with the AttrakDiff scale
timeFrame: after 5 minutes of Digitrack use
measure: User experience assessed with the modular evaluation of the Components of User Experience (meCUE) questionnaire
timeFrame: after 5 minutes of Digitrack use
measure: User engagement
timeFrame: after 5 minutes of Digitrack use
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
References:
citation: Lio G, Fadda R, Doneddu G, Duhamel JR, Sirigu A. Digit-tracking as a new tactile interface for visual perception analysis. Nat Commun. 2019 Nov 26;10(1):5392. doi: 10.1038/s41467-019-13285-0.
citation: Chi MTH, Wylie R. The ICAP Framework: Linking Cognitive Engagement to Active Learning Outcomes. Educational Psychologist. 2014; 49:219-243.