Validation and Standardisation of a "Neuralix" Digital Ecological Battery

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Traumatic Brain Injuries Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital d'Instruction des Armées - Percy

Clamart, 92140, France

Location status: Recruiting

Location contact

Damien Ricard, Professor

CONTACT

[email protected]

0033141466416

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Sensitivity og the Neuralix Battery

Time frame: 36 month

Determine the sensitivity of the Neuralix battery to cognitive disorders post-head trauma of moderate to severe intensity.

Study contacts

Contact information is provided by the study sponsor or research team.

Damien Ricard, Professor

CONTACT

[email protected]

0033141466416

Rachel HAUS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: VANOLIX

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Feb 17, 2025
Registry last updated: Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting