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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01562-43 | Other Identifier | ANSM IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with TBI moderate to severe vs controls
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Damien Ricard, Professor | Contact | 0033141466416 | damien.ricard@m4x.org | |
| Rachel HAUS | Contact | evdg-dpar.contact.fct@intradef.gouv.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital d'Instruction des Armées - Percy | Recruiting | Clamart | 92140 | France |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |