Validation and Standardisation of a "Neuralix" Digital Ecological Battery

NCT06830291 | Recruiting

• 2 other identifiers: 2019PPRC082023-A01562-43
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injuries

Outcome Measures

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.

  36 month

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with TBI moderate to severe vs controls

You may qualify if:

• French-speaking subject aged 18 to 65 years old
• Signed consent to participate

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

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Hôpital d'Instruction des Armées - Percy

Clamart, 92140, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Damien Ricard, Professor

CONTACT

0033141466416; damien.ricard@m4x.org

Rachel HAUS

CONTACT

evdg-dpar.contact.fct@intradef.gouv.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-03

Locations

FR (1)