Traumatic Brain InjuriesVANOLIXNCT06830291
Validation and Standardisation of a "Neuralix" Digital Ecological Battery
An observational study of Traumatic Brain Injuries, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injuries
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with TBI moderate to severe vs controls
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rachel HAUS contact
France1 site, 1 recruiting
- Recruiting
Hôpital d'Instruction des Armées - Percy
Clamart, 92140
Damien Ricard, Professor, 0033141466416, damien.ricard@m4x.org
About this study
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
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity og the Neuralix Battery
Determine the sensitivity of the Neuralix battery to cognitive disorders post-head trauma of moderate to severe intensity.
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start11 Mar 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830291
- Sponsor's protocol ID
- 2019PPRC08
- Other IDs
- 2023-A01562-43
- Acronym
- VANOLIX
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Standardisation of a "Neuralix" Digital Ecological Battery
- ClinicalTrials.gov ID
- NCT06830291
- Acronym / sponsor ID
- VANOLIX / 2019PPRC08
- Conditions
- Traumatic Brain Injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with TBI moderate to severe vs controls
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity og the Neuralix Battery
Time frame: 36 month
Determine the sensitivity of the Neuralix battery to cognitive disorders post-head trauma of moderate to severe intensity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel HAUS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injuries, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damien Ricard, Professor (0033141466416, damien.ricard@m4x.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity og the Neuralix Battery (time frame: 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.