Validation and Standardisation of a "Neuralix" Digital Ecological Battery
Recruiting now
Conditions studied: Traumatic Brain Injuries
In brief
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.
Key facts
- Study ID
- NCT06830291
- Run by
- Direction Centrale du Service de Santé des Armées
- People needed
- 800
- Starts
- 2025-03-11
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2025-04-30
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hôpital d'Instruction des Armées - Percy — Clamart, France (enrolling)
Full record on ClinicalTrials.gov
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