Actively Recruiting
Validation and Standardisation of a "Neuralix" Digital Ecological Battery
Led by Direction Centrale du Service de Santé des Armées · Updated on 2025-04-30
800
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Validation and Standardisation of a "Neuralix" Digital Ecological Battery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- French-speaking subject aged 18 to 65 years old
- Signed consent to participate
- History of moderate to severe head trauma within 5 years prior to study inclusion, meeting high risk criteria by Masters et al. (1987)
You will not qualify if you...
- Visual, hearing, or motor deficits that interfere with cognitive testing
- Insufficient knowledge of counting up to 25, the alphabet, reading, or French writing
- Severe intellectual disability
- Past psychiatric or behavioral disorders requiring specialized care longer than 2 days or current treatment beyond a single anxiolytic
- Current treatment with antidepressants
- Current treatment with antipsychotics or multiple anxiolytics
- Single anxiolytic treatment started or increased less than 1 month ago or current antiepileptic treatment
- Neurological condition or history causing cerebral dysfunction that may affect cognitive assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital d'Instruction des Armées - Percy
Clamart, France, 92140
Actively Recruiting
Research Team
D
Damien Ricard, Professor
CONTACT
R
Rachel HAUS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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