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

Aging Clinical Trial

— DIGICOG-start  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05784623
• Other study ID #: 2021-162
• Status: Completed
• Start date: September 15, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: March 2023
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• User experience
User experience is assessed by validated scales

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (2)

Chi MTH, Wylie R. The ICAP Framework: Linking Cognitive Engagement to Active Learning Outcomes. Educational Psychologist. 2014; 49:219-243.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of the 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.	after 5 minutes of Digitrack use
Secondary	User experience assessed with the AttrakDiff scale	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.	after 5 minutes of Digitrack use
Secondary	User experience assessed with the modular evaluation of the Components of User Experience (meCUE) questionnaire	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	after 5 minutes of Digitrack use
Secondary	User engagement	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.	after 5 minutes of Digitrack use