Dutch University studies Neurological and Neuropsychological Sequelae of COVID-19 Infection
Maastricht University is conducting the clinical trial Neurological and Neuropsychological Sequelae of COVID-19 Infection (NeNeSCo).
COVID-19 is known to affect the respiratory system but may also have an impact on other organ systems, including the brain. A number of severely ill patients also presents neurological symptoms that may be the result of COVID-19 associated brain damage. The aim of this study is to investigate the presence, type, and severity of brain damage as well as the neurological and neuropsychological sequelae of COVID-19 infection. Further, the impact of this infection on daily life functioning, quality of life, and the emotional well-being of family members will be assessed. In this multicenter study, 6-9 months after hospital discharge patients will undergo a 3-T MRI scan and a neuropsychological examination. Additionally, both patients and their family members will answer several questionnaires at 6- 9 and 12-15 months after hospital discharge. COVID-19 patients previously admitted to a general hospital ward will be compared with patients previously admitted to the intensive-care unit. The proposed study will create a more comprehensive picture of the prolonged COVID-19 effects on the brain, mental, and cognitive well-being. The findings will aid patient care and rehabilitation.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV2). COVID-19 primarily affects the respiratory system. However, in severely ill patients damage is also reported to other organ systems including the heart, the kidneys, the circulatory, and gastrointestinal system. Further, research indicates an impact of the virus on the brain and, thereby, on cognition. Patients experience neurological symptoms, MR imaging implies the presence of brain abnormalities, specifically in severely ill patients and studies on cognition suggest problems with memory, attention, information processing and executive function. Preliminary clinical data also show that COVID-19 is associated with neurological and neuropsychiatric illness.
It is planned to include 400 participants.
Actual study start date is December 12, 2020. The researchers expect to complete the study by September 2021.
The population that can be enrolled into this study includes former COVID-19 patients who were either admitted to the general hospital ward or the intensive care unit and their respective family members.
Patients with the following pathologies:
- objectified cognitive impairments before the hospital admission for the COVID-19 infection
- an unexpected incident leading to severe neurological damage occurring after hospital discharge (such as stroke or traumatic brain injury)
- contra-indications for MRI scanning (e.g. metal implants, cardiac pacemaker, claustrophobia, pregnancy).
are excluded from participation.
Hersenstichting, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) and UMC Utrecht are the collaborator in this clinical trial.
The location of the study is as follows (further details can be found here https://ichgcp.net/clinical-trials-registry/NCT04745611) Maastricht, Netherlands; Amsterdam and Utrecht, Netherlands.
