Clinical trial NCT06171568: Lariboisière Cognitive Assessment: Evaluation of the 1-year Outcomes
Official title: Study of the One-year Outcomes of Patients Hospitalized in the Lariboisière Neurosurgery Department
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injuries
Keywords: Brain injuries
Prognosis
Cognitive impairment
Cognition
Executive Function
Neuropsychological tests
Neuro-rehabilitation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: SBT Human(s) Matter
First posted: 2023-12-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at Lariboisière hospital in neurosurgery unit between February 2023 and February 2024.

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.

Detailed description: Traumatic brain injuries (TBI) are responsible for about 262 hospitalizations per 100,000 inhabitants in Europe each year. After a traumatic brain injury, 704 out of 100,000 individuals experience long-term consequences, including motor and/or balance disorders, fatigue, chronic pain, psychological disorders, and cognitive impairments such as memory problems, difficulties in comprehension, attentional deficits, and impairment of working memory. Without adequate rehabilitation, cognitive impairments can persist for several years, leading to significant socio-professional consequences such as job loss and social isolation, as well as medical and economic consequences.

The Paris TBI study showed that upon discharge from acute care services, only 45% of patients who had suffered severe traumatic brain injuries were referred to specialized rehabilitation facilities, while 30% returned directly home. Additionally, there is a lack of cognitive assessment in acute care services. For instance, in services that treat stroke patients, only 61% of patients will meet with a rehabilitation professional before their discharge. Short cognitive screening batteries typically used in the acute phase to guide patients' discharge from the hospital include the Montreal Cognitive Assessment (MoCA) or the Mini-Mental State Examination (MMSE). However, these scores are not very specific or sensitive, are examiner-dependent, and require trained personnel. Currently, there are few validated digital cognitive assessment batteries available for acute-phase evaluation and routine use in traumatic brain injury patients. Furthermore, evaluating cognitive impairments early after a traumatic brain injury can be challenging due to various confounding factors (e.g., fatigue, stressful hospitalization context) and organizational factors. Nevertheless, early assessment of cognitive impairments remains essential in order to appropriately refer patients, if necessary, to specialized rehabilitation facilities.

To address the need for better early detection of cognitive impairment following brain injuries, the investigators have developed the Cognitive Evaluation of Lariboisière (also known as Cog-First), a screening battery for cognitive impairments on a tablet device that can be quickly and independently completed by patients. Cog-First is now integrated into routine care in Lariboisière as a systematic pre-discharge assessment for patients discharged home without rehabilitation plan.

The main goal of this project is to identify patients who are at risk of experiencing cognitive impairments that could significantly impact their long-term functional prognosis. The investigators will evaluate whether the initial results obtained through the systematic evaluation using Cog-First at the time of discharge can accurately predict the functional and cognitive outcomes at one year. This could enable us to identify at-risk patients before discharge from acute care and refer them to specialized rehabilitation units earlier, leading to improved future outcomes for these individuals.

During the 1-year follow-up consultation after hospital discharge, eligible patients will be offered the opportunity to participate in the study. If they consent, their functional and cognitive abilities will be assessed using a set of tests and questionnaires. The assessments will include the modified Rankin score, IADL questionnaire, MoCA, Bref, Rivermead questionnaire, SF-36 questionnaire, CIQ-R questionnaire, and PCL-5 questionnaire.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of the independence of patients in their daily life.
timeFrame: 1 year
measure: Mesure of different cognitive functions of patients (language, memory, visio-spatial functions, attention, concentration, orientation in time and space).
timeFrame: 1 year
measure: Assess various cognitive functions in patients, including language, memory and visio-spatial abilities
timeFrame: 1 year
measure: Rivermead questionnaire
timeFrame: 1 year after discharge from Neurosurgery department of Lariboisière
measure: Short Form (36) Health Survey (SF-36)
timeFrame: 1 year after discharge from Neurosurgery department of Lariboisière
measure: Community Integration Questionnaire - Revised (CIQ-R)
timeFrame: 1 year after discharge from Neurosurgery department of Lariboisière
measure: Posttraumatic stress disorder CheckList (PCL-5)
timeFrame: 1 year after discharge from Neurosurgery department of Lariboisière
Other outcomes:
Locations:
city: Paris
country: France
facility: Neurosurgery - Lariboisière hospital
state: Ile-de-France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Emmanuel Mandonnet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alexis Schnitzler, MD, PhD
role: STUDY_DIRECTOR
References:
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