Validation and Standardisation of a "Neuralix" Digital Ecological Battery (VANOLIX)

Direction Centrale du Service de Santé des Armées

Status

Enrolling

Conditions

Traumatic Brain Injuries

Study type

Observational

Funder types

Other

Identifiers

NCT06830291

2019PPRC08

2023-A01562-43 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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