Validation of a digital tool for assessing cognitive functions after head trauma
Validation and Standardisation of a "Neuralix" Digital Ecological Battery
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 |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Direction Centrale du Service de Santé des Armées Academic / other |
| Locations | 1 site (Clamart) |
| Trial ID | NCT06830291 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with significant visual, hearing, or motor deficits that interfere with cognitive testing may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Clamart
- Hôpital d'Instruction des Armées - Percy — Clamart, France (Recruiting)
Study contacts
- Study coordinator: Damien Ricard, Professor
- Email: damien.ricard@m4x.org
- Phone: 0033141466416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.