Validation and Standardisation of a "Neuralix" Digital Ecological Battery

Last updated: April 29, 2025
Sponsor: Direction Centrale du Service de Santé des Armées
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT06830291
2019PPRC08
2023-A01562-43
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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 thehigh risk criteria of the study by Masters et al. (1987) at the time of the headtrauma, and occurred a maximum of 5 years after inclusion in the VANOLIX study

Exclusion

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 aspecialized environment or requiring current treatment other than a singleanxiolytic

  • Current treatment with antidepressant

  • Current treatment with antipsychotic or multiple anxiolytics

  • Single anxiolytic treatment initiated or increased for less than 1 month or currentantiepileptic treatment

  • Subject with a neurological condition or a history leading to cerebral dysfunctionlikely to interfere with the cognitive assessment

Study Design

Total Participants: 800
Study Start date:
March 11, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Hôpital d'Instruction des Armées - Percy

    Clamart, 92140
    France

    Active - Recruiting

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