AgingDIGICOG-startNCT05784623
Interest and Feasibility of the DIGItracking Technique for the Early Diagnosis of COGnitive Disorders
An observational study of Aging, run by University Hospital, Angers at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aging
- What is being tested?
- User experience
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2021to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All consecutive patients meeting the eligibility criteria over the study period.
Who may be able to join
- Men or women ≥ 75 years old
- Consultation or hospitalization in geriatrics department
- Subjects who can give written consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Aging
- Being tested
- User experience
- Keywords
- digit-tracking, elderly, neurocognitive disorders, usability, user experience
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
User experienceOther
User experience is assessed by validated scales
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 5 minutes of Digitrack use
Secondary outcomes (3)
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.
Measured: after 5 minutes of Digitrack use
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
Measured: after 5 minutes of Digitrack use
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.
Measured: after 5 minutes of Digitrack use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start15 Sep 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784623
- Sponsor's protocol ID
- 2021-162
- Acronym
- DIGICOG-start
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are not planned to be shared with other researchers
Publications
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.
PubMed 31772154Chi MTH, Wylie R. The ICAP Framework: Linking Cognitive Engagement to Active Learning Outcomes. Educational Psychologist. 2014; 49:219-243.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05784623
- Acronym / sponsor ID
- DIGICOG-start / 2021-162
- Conditions
- Aging
- Keywords
- digit-tracking, elderly, neurocognitive disorders, usability, user experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 27 Mar 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All consecutive patients meeting the eligibility criteria over the study period.
Key inclusion criteria (3 listed)
- Men or women ≥ 75 years old
- Consultation or hospitalization in geriatrics department
- Subjects who can give written consent to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| User experienceUser experience is assessed by validated scales | Other | – |
Primary outcome
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.
3 secondary outcomes
User experience assessed with the AttrakDiff scale
Time frame: after 5 minutes of Digitrack use
User experience assessed with the modular evaluation of the Components of User Experience (meCUE) questionnaire
Time frame: after 5 minutes of Digitrack use
User engagement
Time frame: after 5 minutes of Digitrack use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 31772154Lio 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.
- BackgroundChi MTH, Wylie R. The ICAP Framework: Linking Cognitive Engagement to Active Learning Outcomes. Educational Psychologist. 2014; 49:219-243.
- Individual participant dataSharing planned: No. IPD are not planned to be shared with other researchers
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Aging, run by University Hospital, Angers at 1 site in France.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 27 Mar 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of the Digitrack use (time frame: after 5 minutes of Digitrack use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05784623, which also lists 2 linked publications.
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 27 Mar 2023.