ClinConnect ClinConnect Logo
Search / Trial NCT06830291

Validation and Standardisation of a "Neuralix" Digital Ecological Battery

Launched by DIRECTION CENTRALE DU SERVICE DE SANTÉ DES ARMÉES · Feb 11, 2025

Trial Information

Current as of September 07, 2025

Recruiting

Keywords

ClinConnect Summary

The VANOLIX study is looking at a new digital tool called the Neuralix battery, designed to assess cognitive functions in adults who have experienced moderate to severe traumatic brain injuries. This tool aims to improve the way we measure memory and thinking skills after head trauma, addressing some of the limitations of existing tests. By comparing results from head trauma patients with those from healthy volunteers, researchers hope to validate and standardize this new assessment method, making it more reliable for doctors and researchers.

To participate in the study, you must be a French-speaking adult between 18 and 65 years old who has had a serious head injury within the last five years. You'll need to provide consent to join the study. However, individuals with certain conditions, like significant visual or hearing impairments, severe intellectual disabilities, or specific psychiatric disorders, will not be eligible. If you join, you can expect to take part in cognitive tests using the Neuralix app, which will help researchers understand how well it works in evaluating cognitive functions in people with head injuries.

Gender

ALL

Eligibility 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

About Direction Centrale Du Service De Santé Des Armées

The Direction Centrale du Service de Santé des Armées (DCSSA) is a key entity within the French Ministry of Armed Forces, responsible for overseeing the health services of military personnel. As a clinical trial sponsor, DCSSA is dedicated to advancing medical research and innovation to enhance the health and well-being of service members. It collaborates with various stakeholders, including academic institutions and healthcare organizations, to conduct rigorous clinical trials that adhere to stringent ethical and regulatory standards. Through its commitment to scientific excellence and patient safety, DCSSA aims to contribute valuable insights to the field of military medicine and broader healthcare practices.

Locations

Clamart, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported