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RecruitingNCT06830291VANOLIXUpdated Aug 28, 2026

Validation and Standardisation of a "Neuralix" Digital Ecological Battery

An observational study in Traumatic Brain Injuries, sponsored by Direction Centrale du Service de Santé des Armées. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Direction Centrale du Service de Santé des Armées · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Traumatic Brain Injuries
03

In context

Brain Injuries, Traumatic

1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.

This study's planned enrollment of 800 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.

Browse Brain Injuries, Traumatic studies →

Lead sponsor

Direction Centrale du Service de Santé des Armées is the lead sponsor of 95 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with TBI moderate to severe vs controls

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • G1 : Control group: single assessment

    healthy volunteers undergo the test battery only once

  • G2 :Control group: double assessment

    healthy volunteers undergo the test battery twice, six months apart

  • G3 :Patient group: single assessment

    patients undergo the test battery only once

  • G4 : Patient group: double assessment

    patients undergo the test battery twice, six months apart

06

What researchers measure

Primary outcomes

  1. Sensitivity og the Neuralix Battery

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

    Time frame: 36 month

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06830291
Lead sponsor
Direction Centrale du Service de Santé des Armées
Responsible party
Sponsor
First posted
Feb 17, 2025
Start date
Mar 11, 2025
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Aug 28, 2026

Study contacts

Damien Ricard, Professor
Contact
damien.ricard@m4x.org
0033141466416

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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