Lariboisière Cognitive Assessment: Evaluation of the 1-year Outcomes

NCT06171568 | Recruiting

• 2 other identifiers: APHP2305282023-A00386-39
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive sequelae are common following acquired brain injuries. However, their detection can be challenging, particularly in acute care units such as neurosurgery. Specific screening in acute phase is critical for early detection and proper orientation. The Lariboisière cognitive assessment (Cog-First) is a brief cognitive evaluation conducted on a touch-screen tablet for patients with acquired brain injuries in the acute phase, which is integrated into routine care in Lariboisière. The objective of this project is to evaluate the one-year cognitive and functional outcomes of patients who have undergone hospitalization in neuro-surgery. The primary aim is to assess whether the systematic pre-discharge assessment (Cog-First) performed as part of routine care can predict a poor functional prognosis and help identify at-risk patients earlier and more effectively.

Conditions

Brain Injuries

Keywords

Brain injuries; Prognosis; Cognitive impairment; Cognition; Executive Function; Neuropsychological tests; Neuro-rehabilitation

Outcome Measures

Primary Outcomes (1)

• Evaluation of the functional outcome at 1 year of patients who were hospitalized in the Lariboisière neurosurgery department compared with the initial systematic cognitive assessment (Cog-First)

  The Modified Rankin Scale (MRS) will be used during the systematic follow-up consultation. The MRS is a score allowing functional independence level notation from 0 (no symptoms or incapacity) to 5 (severe disability).

  1 year

Secondary Outcomes (7)

• Assessment of the independence of patients in their daily life.

  1 year

• Mesure of different cognitive functions of patients (language, memory, visio-spatial functions, attention, concentration, orientation in time and space).

  1 year

• Assess various cognitive functions in patients, including language, memory and visio-spatial abilities

  1 year

• Rivermead questionnaire

  1 year after discharge from Neurosurgery department of Lariboisière

• Short Form (36) Health Survey (SF-36)

  1 year after discharge from Neurosurgery department of Lariboisière

Interventions

Tests and questionnaires OTHER

1 year after discharge from neurosurgery department, included patients will answer to the: * Modified Rankin Scale; * Instrumental Activities of Daily Living (IADL) questionnaire; * Montreal Cognitive Assessment (MoCA); * Frontal assessment battery (BREF); * Rivermead questionnaire; * Short Form (36) Health Survey (SF-36) * Community Integration Questionnaire - Revised (CIQ-R) * Posttraumatic stress disorder CheckList (PCL-5)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized at Lariboisière hospital in neurosurgery unit between February 2023 and February 2024.

You may qualify if:

• Patient over 18 years of age
• Patient hospitalized in neurosurgery unit at Lariboisière hospital between February 2023 and February 2024
• Patient discharged home
• Patient affiliated to the social security system
• Patient having expressed no opposition

You may not qualify if:

• Patient transferred to a rehabilitation facility following hospitalization in neurosurgery
• History of neurological or psychiatric illness
• Severe uncorrected visual impairment and/or aphasia
• Non-French-speaking patients
• Patients receiving State Medical Aid (AME)
• Patients under guardianship/curatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• SBT Human(s) Matter: collaborator

Study Sites (1)

Neurosurgery - Lariboisière hospital

Paris, Île-de-France Region, 75010, France

RECRUITING

Related Publications (8)

• Peeters W, van den Brande R, Polinder S, Brazinova A, Steyerberg EW, Lingsma HF, Maas AI. Epidemiology of traumatic brain injury in Europe. Acta Neurochir (Wien). 2015 Oct;157(10):1683-96. doi: 10.1007/s00701-015-2512-7. Epub 2015 Aug 14.

  PMID: 26269030 BACKGROUND

• Jourdan C, Azouvi P, Genet F, Selly N, Josseran L, Schnitzler A. Disability and Health Consequences of Traumatic Brain Injury: National Prevalence. Am J Phys Med Rehabil. 2018 May;97(5):323-331. doi: 10.1097/PHM.0000000000000848.

  PMID: 29016402 BACKGROUND

• Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.

  PMID: 16983222 BACKGROUND

• Stocchetti N, Zanier ER. Chronic impact of traumatic brain injury on outcome and quality of life: a narrative review. Crit Care. 2016 Jun 21;20(1):148. doi: 10.1186/s13054-016-1318-1.

  PMID: 27323708 BACKGROUND

• Jourdan C, Bayen E, Bosserelle V, Azerad S, Genet F, Fermanian C, Aegerter P, Pradat-Diehl P, Weiss JJ, Azouvi P; Members of the Steering Committee of the PariS-TBI Study. Referral to rehabilitation after severe traumatic brain injury: results from the PariS-TBI Study. Neurorehabil Neural Repair. 2013 Jan;27(1):35-44. doi: 10.1177/1545968312440744. Epub 2012 Mar 28.

  PMID: 22460612 BACKGROUND

• Schnitzler A, Erbault M, Solomiac A, Sainte Croix D, Fouchard A, May-Michelangeli L, Grenier C. Early rehabilitation after stroke: Strong recommendations but no achievement in the French Acute Healthcare Facilities. Ann Phys Rehabil Med. 2019 Jan;62(1):58-59. doi: 10.1016/j.rehab.2018.07.001. Epub 2018 Jul 19. No abstract available.

  PMID: 30031892 BACKGROUND

• Rodrigues JC, Becker N, Beckenkamp CL, Mina CS, de Salles JF, Bandeira DR. Psychometric properties of cognitive screening for patients with cerebrovascular diseases A systematic review. Dement Neuropsychol. 2019 Jan-Mar;13(1):31-43. doi: 10.1590/1980-57642018dn13-010004.

  PMID: 31073378 BACKGROUND

• de Guise E, Leblanc J, Champoux MC, Couturier C, Alturki AY, Lamoureux J, Desjardins M, Marcoux J, Maleki M, Feyz M. The mini-mental state examination and the Montreal Cognitive Assessment after traumatic brain injury: an early predictive study. Brain Inj. 2013;27(12):1428-34. doi: 10.3109/02699052.2013.835867. Epub 2013 Oct 8.

  PMID: 24102622 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Cognitive Dysfunction

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Emmanuel Mandonnet, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Alexis Schnitzler, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Camille Heslot, MD

CONTACT

01.49.95.81.69; camille.heslot@aphp.fr

Alexis Schnitzler, MD, PhD

CONTACT

01.40.05.49.58; alexis.schnitzler@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: March 22, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)