Clinical trial NCT06830291: Validation and Standardisation of a "Neuralix" Digital Ecological Battery
Official title: Validation and Standardisation of a "Neuralix" Digital Ecological Battery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injuries
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with TBI moderate to severe vs controls

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity og the Neuralix Battery
timeFrame: 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées - Percy
Study officials:
References: