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NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation

NCT06876948 · Azienda Ospedaliero, Universitaria Pisana
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Official title
STUDY of NEUROLOGICAL COMPLICATIONS of LONG COVID-19 in CHILDREN and ADOLESCENTS; NEUROPSYCHIATRIC, ELECTROENCEPHALOGRAPHIC and NEURORADIOLOGICAL INVESTIGATIONS
About this study
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 Criteria: * 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 Criteria: * 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
Study design
Enrollment target: 100 participants
Allocation: na
Masking: none
Age groups: child
Timeline
Starts: 2023-03-29
Estimated completion: 2026-04-28
Last updated: 2025-03-14
Interventions
Diagnostic Test: Psychological tests, EEG, Magnetic Resonance
Primary outcomes
  • Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1. (Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1).)
Sponsor
Azienda Ospedaliero, Universitaria Pisana · other
Contacts & investigators
ContactAlessandro Orsini, Dirigente medico · contact · neuropediatriapisa@gmail.com · +050 995995
All locations (1)
Azienda Ospedaliera Universitaria PisanaRecruiting
Pisa, PI, Italy
NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation · TrialPath