Validation of a digital tool for assessing cognitive functions after head trauma
Official title: Validation and Standardisation of a "Neuralix" Digital Ecological Battery
Run by Direction Centrale du Service de Santé des Armées · NCT06830291 · Data updated 2026-11-12
This study is testing a new online tool to see if it can better measure memory and thinking skills in French-speaking adults who have had serious head injuries.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | Direction Centrale du Service de Santé des Armées Academic / other |
| Locations | 1 site (Clamart) |
| Status | Recruiting |
| Started | March 11, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | August 28, 2026 |
| Trial ID | NCT06830291 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are French-speaking adults aged 18 to 65 who have experienced moderate to severe head trauma within the last five years.
✕Probably not a fit
Patients with significant visual, hearing, or motor deficits that interfere with cognitive testing may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to validate and standardize the Neuralix digital ecological battery, which is designed to assess cognitive disorders in adults who have experienced traumatic brain injuries. The battery focuses on evaluating memory and executive functions, addressing limitations of existing neuropsychological tests. By utilizing an online application, the study seeks to provide a comprehensive assessment of cognitive functions while improving the sensitivity of results through better decision criteria. Participants will be French-speaking adults aged 18 to 65 with a history of moderate to severe head trauma.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of cognitive impairments in patients with traumatic brain injuries.
How similar studies have gone: While there may be existing studies on cognitive assessments, the specific approach of the Neuralix battery is novel and aims to address known limitations in current methods.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hôpital d'Instruction des Armées - Percy
Clamart, France Recruiting
Study contacts
- Study coordinator: Damien Ricard, Professor
- Email: damien.ricard@m4x.org
- Phone: 0033141466416
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.