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Clinical Trials in France / NCT06830291
Recruiting Observational

Validation and Standardisation of a "Neuralix" Digital Ecological Battery

NCT06830291 · tracked via the Priya Life Science France tracker
Sponsor
Direction Centrale du Service de Santé des Armées
Phase
Observational
Started
2025-03-11
Last updated
2026-08-28

Condition(s) studied

Traumatic Brain Injuries

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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 outcome measure(s)

  • Sensitivity og the Neuralix Battery — 36 month
    Determine the sensitivity of the Neuralix battery to cognitive disorders post-head trauma of moderate to severe intensity.

Trial sites (1)

FacilityCityRegionStatus
Hôpital d'Instruction des Armées - Percy Clamart France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06830291 on ClinicalTrials.gov ↗ ← All trials in France