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Completed

NCT Number: NCT05784623

Interest and Feasibility of the DIGItracking Technique for the Early Diagnosis of COGnitive Disorders

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital

Angers, 49000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

User experience

Other

User experience is assessed by validated scales

Primary outcomes

  1. Success rate of the Digitrack use

    Time frame: after 5 minutes of Digitrack use

    The number of patients able to complete the training and evaluation phases with the Digitrack, consisting of the exploration of 3 and at least 20 images respectively.

Secondary outcomes

  1. User experience assessed with the AttrakDiff scale

    Time frame: after 5 minutes of Digitrack use

    The AttrakDiff is composed of 28 items. Each item is presented as a 7-point semantic differential (e.g. "simple - complicated"). The rates range between -3 and 3, 0 being the neutral value. The scores are averaged across the population.

  2. User experience assessed with the modular evaluation of the Components of User Experience (meCUE) questionnaire

    Time frame: after 5 minutes of Digitrack use

    The module II 'emotions' of the meCUE questionnaire is used. It is composed of 8 items. Each item is presented as emotional sentences (e.g. "The product excites me.") and the user rates his agreement with the sentence on a 7-point Likert scale. The scores are averaged across the population

  3. User engagement

    Time frame: after 5 minutes of Digitrack use

    The user engagement is classified according to an internally developped scale including 5 levels : 'interactive', 'constructive', 'active', 'passive', 'disengaged'. The experimenter attributes the level of engagement according to the participant's dominant behavior during the whole experimental procedure.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

DIGICOG-start: Intérêt et faisabilité de la Technique de DIGItracking Pour Diagnostiquer précocement Les Troubles de la COGnition au Cours de la Vie

Acronym: DIGICOG-start

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2023
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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