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Brain InjuriesECOGNCT06171568

Lariboisière Cognitive Assessment: Evaluation of the 1-year Outcomes

An observational study of Brain Injuries, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Injuries
What is being tested?
Tests and questionnaires
How many people
400 participants
Where
1 siteFrance
Study dates
22 Mar 2024to Mar 2025
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Camille Heslot, MD contact

01.49.95.81.69 ext. +33

camille.heslot@aphp.fr

Alexis Schnitzler, MD, PhD contact

01.40.05.49.58 ext. +33

alexis.schnitzler@aphp.fr

France1 site, 1 recruiting

  • Neurosurgery - Lariboisière hospital

    Paris, Île-de-France Region, 75010

    Camille Heslot, MD, 01.49.95.81.69 ext. +33, camille.heslot@aphp.fr

    Emmanuel Mandonnet, MD, PhD, 01.49.95.81.69 ext. +33, emmanuel.mandonnet@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Study of the One-year Outcomes of Patients Hospitalized in the Lariboisière Neurosurgery Department

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.

Read the 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.

Conditions
Brain Injuries
Being tested
Tests and questionnaires
Keywords
Brain injuries, Prognosis, Cognitive impairment, Cognition, Executive Function, Neuropsychological tests, Neuro-rehabilitation
Medical subject headings
Brain Injuries, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tests and questionnairesOther

    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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 year

Secondary outcomes (7)

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

    The Instrumental Activities of Daily Living (IADL) questionnaire will be submitted to patients.

    The IADL questionnaire gives a score going from 0 to 8. Higher score mean a better outcome.

    Measured: 1 year

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

    Montreal Cognitive Assessment (MoCA) will be the used tool to answer this outcome.

    The MoCA gives a score going from 0 to 30. Higher score mean a better outcome.

    Measured: 1 year

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

    The "Batterie Rapide d'Efficience Frontale" (BREF) test is a frontal assessment battery which will be used to question patients.

    The BREF test gives a score going from 0 to 18. Higher score mean a better outcome.

    Measured: 1 year

  4. Rivermead questionnaire

    Assessment of the post-concussion syndrome. The Rivermead questionnaire gives a score going from 0 to 52. Higher score mean a worse outcome.

    Measured: 1 year after discharge from Neurosurgery department of Lariboisière

  5. Short Form (36) Health Survey (SF-36)

    Assessment of quality of life. The SF-36 gives a score going from 0 to 100. Higher score mean a better outcome.

    Measured: 1 year after discharge from Neurosurgery department of Lariboisière

  6. Community Integration Questionnaire - Revised (CIQ-R)

    Assessment of socio-professional reintegration. The CIQ-R gives a score going from 0 to 35. Higher score mean a better outcome.

    Measured: 1 year after discharge from Neurosurgery department of Lariboisière

  7. Posttraumatic stress disorder CheckList (PCL-5)

    Assessment of post-traumatic stress. The PCL-5 gives a score going from 0 to 80. Higher score mean a worse outcome.

    Measured: 1 year after discharge from Neurosurgery department of Lariboisière

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2023
  2. Study start22 Mar 2024
  3. Primary completionMar 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

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
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06171568
Sponsor's protocol ID
APHP230528
Other IDs
2023-A00386-39
Acronym
ECOG
Status last verified
May 2024
First submitted
6 Dec 2023
Last updated
31 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26269030

  • 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.

    PubMed 29016402

  • 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.

    PubMed 16983222

  • 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.

    PubMed 27323708

  • 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.

    PubMed 22460612

  • 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.

    PubMed 30031892

  • 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.

    PubMed 31073378

  • 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.

    PubMed 24102622

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Injuries, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 May 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Camille Heslot, MD (01.49.95.81.69 ext. +33, camille.heslot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06171568, which also lists 8 linked publications.

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 31 May 2024.

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