NCT06830291 Validation and Standardisation of a "Neuralix" Digital Ecological Battery
| NCT ID | NCT06830291 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Direction Centrale du Service de Santé des Armées |
| Condition | Traumatic Brain Injuries |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2025-03-11 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06830291 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Traumatic Brain Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06830291 currently recruiting?
Yes, NCT06830291 is actively recruiting participants. Contact the research team at damien.ricard@m4x.org for enrollment information.
Where is the NCT06830291 trial being conducted?
This trial is being conducted at Clamart, France.
Who is sponsoring the NCT06830291 clinical trial?
NCT06830291 is sponsored by Direction Centrale du Service de Santé des Armées. The trial plans to enroll 800 participants.