NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychological tests, EEG, Magnetic Resonance.
- Who it may be relevant to
- Registry conditions: Long Covid-19. Basic parameters: 6 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
STUDY of NEUROLOGICAL COMPLICATIONS of LONG COVID-19 in CHILDREN and ADOLESCENTS; NEUROPSYCHIATRIC, ELECTROENCEPHALOGRAPHIC and NEURORADIOLOGICAL INVESTIGATIONS
Overview
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.
Interventions
- Diagnostic test Psychological tests, EEG, Magnetic Resonance
Patients are administered some psychological tests, if they are positive they move on to the next stage, otherwise the patients leave the practice. If they are positive, EEG, MRI and other psychological tests are also administered.
Primary outcome measures
- Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1. [Time frame: Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Azienda Ospedaliera Universitaria Pisana — Pisa
Identifiers
NCT: NCT06876948 · GR-2021-1237536 · D65E2000350001