Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05111275 |
| Other study ID # |
MEMO |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
September 30, 2028 |
Study information
| Verified date |
June 2023 |
| Source |
University of Liege |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study concerns patients who survived intensive care, after a minimum stay of 7 days and
presenting cognitive disorders (with a score ≤ 26 on the MoCA test) during the post-intensive
care follow-up consultation one month after ICU discharge.
The objective of this prospective open-label randomized study is to assess the impact of
cognitive stimulation on recovery from cognitive impairment after a critical illness.
Description:
Patients who survive a critical illness and a stay in intensive care may present a
post-intensive care syndrome. This syndrome comprises in particular cognitive disorders, with
memory disorders and executive disorders. The systemic inflammatory reaction seems to play an
important role in the genesis of these disorders. Frequently reported risk factors are
numerous and include hypoxemia, hypotension, glycemic dysregulation, drug toxicities, and,
delirium.
In post-intensive care, these cognitive disorders are most often detected using screening
tests that quickly and superficially assess the major components of cognition. During the
standardized screening that we offer to patients who join the follow-up clinic of our
university hospital, we use the MoCA (Montreal Cognitive Assessment) as a screening test. In
a series of patients who survived a severe form of COVID-19, we observed that more than 80%
of patients did not achieve the maximum score on this test (MoCA <30/30) 3 months after ICU
discharge, thus signifying the presence of cognitive impairment. Half of these patients had
mild disorders (MoCA> 26/30), the other half had more pronounced disorders, based on commonly
accepted cut-off values (MoCA ≤ 26/30). Similar data are reported in other populations:
cognitive disorders are frequently encountered after ARDS of other etiologies [5, 6], and may
persist for several years after the acute episode [7].
In Belgium, access to an exhaustive cognitive assessment and cognitive rehabilitation is
subject to different access criteria, which are not necessarily met by patients who have
survived intensive care. Such rehabilitation is then quite expensive for the patient.
Patients with cognitive impairment after intensive care may nevertheless benefit from aids in
cognitive recovery. In a few rare studies, it seems that non-specific cognitive training can
improve the cognitive outcome of patients who have survived intensive care [8].
According to several neuropsychologists interviewed as part of a preliminary investigation,
there are cognitive stimulation tools that could activate spontaneous cognitive recovery in
post-intensive care. Among them, the MEMO website (http://www.memory-motivation.org/home-2/)
offers free access to batteries of cognitive exercises. This website was created by a team of
psychologists, doctors, engineers and researchers in connection with the University of Nice
Sophia Antipolis. It was designed to meet the needs of patients with cognitive disorders,
healthcare professionals involved in prevention, rehabilitation and cognitive stimulation.
This computer hardware playfully stimulates memory, attention, executive functions, language
and gnosias. Several levels of difficulty are foreseen. In addition, the prescriber, by
creating a professional profile on the website, can monitor the compliance and performance of
patients to whom he has advised this platform.
This tool is intended as a means of stimulating cognitive recovery, but does not replace
neuropsychological management in the event of persistent cognitive disorders.
The aim of our prospective randomized study is to assess the impact of cognitive stimulation
on the course of cognitive impairment within two months of discharge from intensive care.
Cognitive exercise cannot be offered too soon after the critical episode because patients are
extremely tired. On the contrary, these exercises cannot be postponed too long in order to
optimize the recovery as quickly as possible to the best possible functional state.
