Validation and Standardisation of a "Neuralix" Digital Ecological Battery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-11

Study Completion Date

2027-03-31

Brief Summary

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The management of head trauma patients requires the assessment of cognitive disorders using standardized neuropsychological tests and questionnaires. However, the evaluation tools currently available present well-identified limitations limiting the accuracy of the measurements (in a non-exhaustive manner, let us cite for example the absence of control of the rate of "false positives" or even the impossibility of measuring the improvement or decline in performance over time). In order to overcome these limitations, the Neuralix battery was created with particular attention to the assessment of memory and executive functions largely impacted after head trauma. The Neuralix battery comes in the form of a digital application accessible online and allowing a global assessment of cognitive functions in adults. In addition, the processing of results includes the operationalization of decision criteria taking into account the limitations cited above in order to improve the sensitivity of the evaluation.

The VANOLIX study proposes the validation of the Neuralix cognitive battery with head trauma patients of moderate to severe intensity as well as its standardization with healthy volunteers, these two steps being essential to making the tool available to clinician-researchers.

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Detailed Description

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Conditions

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Traumatic Brain Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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G1 : Control group: single assessment

healthy volunteers undergo the test battery only once

No interventions assigned to this group

G2 :Control group: double assessment

healthy volunteers undergo the test battery twice, six months apart

No interventions assigned to this group

G3 :Patient group: single assessment

patients undergo the test battery only once

No interventions assigned to this group

G4 : Patient group: double assessment

patients undergo the test battery twice, six months apart

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* French-speaking subject aged 18 to 65 years old
* Signed consent to participate
* History of head trauma of moderate to severe intensity, i.e. having presented the high risk criteria of the study by Masters et al. (1987) at the time of the head trauma, and occurred a maximum of 5 years after inclusion in the VANOLIX study

Exclusion Criteria

* Visual or hearing or motor deficit disrupting the taking of cognitive tests
* Subject with insufficient knowledge of counting (up to 25), the alphabet, reading, or French writing
* Subject with a severe intellectual disability
* Subject with past psychiatric or behavioral disorders requiring a stay \>2 days in a specialized environment or requiring current treatment other than a single anxiolytic
* Current treatment with antidepressant
* Current treatment with antipsychotic or multiple anxiolytics
* Single anxiolytic treatment initiated or increased for less than 1 month or current antiepileptic treatment
* Subject with a neurological condition or a history leading to cerebral dysfunction likely to interfere with the cognitive assessment

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes