Trials / Completed
CompletedNCT05307575
Neurobehavior and Brain Connectivity in Post COVID-19 Patients
Cognition, Emotion/Behavior, Functionality and Brain Connectivity in Recovered COVID-19 Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 630 (actual)
- Sponsor
- Consorci Sanitari de Terrassa · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
COVID-19 neurological effects can generate long-term neurobehavioral dysfunction. Our main objective is to examine the impact of COVID-19 on neurobehavior and its relationship with illness severity. Besides, we aim to study structural and functional brain connectivity in a subsample of middle-aged post-COVID-19 individuals. Finally, we aim to develop predictive models of neurobehavioural evolution in post-COVID-19 based on multimodal data.
Detailed description
NAUTILUS is an observational, cross-sectional, and multicenter study. It will be performed at 22 public hospitals. Two groups of COVID-19 adults (Severe N=210, Moderate-mild N=210, WHO criteria) reporting cognitive complaints will compare to healthy controls (N=210). They will be assessed on neurobehavioral status. We will perform brain MRI in a subsample (N=120, 40 per group), and we will obtain potential biomarkers of neural damage (smell function, retinal blood plexuses integrity, and inflammation). Moreover, we will use machine learning-based algorithms based on demographics, previous pathologies, lifestyle, clinical data, and biomarkers to predict neurobehavioral models. Expected results: Identify the neurobehavioral impact of post-COVID-19 individuals and the discriminative power of multimodal biomarkers in adverse outcomes. Our result would help develop clinically useful models to predict the neurobehavioral impact to develop future personalized and preventive intervention strategies.
Conditions
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2024-09-15
- Completion
- 2024-09-15
- First posted
- 2022-04-01
- Last updated
- 2024-09-19
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05307575. Inclusion in this directory is not an endorsement.