Status:
RECRUITING
NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation
Lead Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Conditions:
Long Covid-19
Eligibility:
All Genders
6-16 years
Phase:
NA
Brief Summary
The study seeks to investigate the neurological effects caused by Covid-19 in children and adolescents in the 6-16 age group. To do this, neuropsychological scales, an EEG and an MRI were used.
Eligibility Criteria
Inclusion
- Age between 6 years and 16 years and 11 months
- Symptomatology compatible with long neurological COVID, specifically: persistence or appearance of new neurological signs/symptoms (e.g. fatigue, headache, sleep disturbance, cognitive dysfunction, memory difficulties, emotional or mood disorders, vertigo cognitive dysfunction, memory difficulties, emotional or mood disorders, dizziness, dysautonomia, movement disorders movement disorders, ataxia, tremor, epilepsy, muscle weakness, myalgia, hyposmia, hypogeusia hearing loss or tinnitus and/or sensorimotor deficits such as hypoesthesia, dysesthesia) after three months after established SARS-CoV-2 infection, as well as persistence of these symptoms for at least two months, in the absence of a clear aetiology.
- Signature of the appropriate Informed Consent by caregiver(s) and patient(s)
Exclusion
- Poor knowledge of the Italian language or other limitation of verbal communication that compromises the subject's ability to perform neuropsychological tests
- Need for sedation to perform brain MRI 7 Tesla
- Neurological or neuropsychiatric disorder diagnosed prior to COVID-19 diagnosis
- Caregiver's failure to sign consent
Key Trial Info
Start Date :
March 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 28 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06876948
Start Date
March 29 2023
End Date
April 28 2026
Last Update
March 14 2025
Active Locations (1)
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1
Azienda Ospedaliera Universitaria Pisana
Pisa, PI, Italy, 56126