NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophys… (NCT06876948) | Clinical Trial Compass
RecruitingNot Applicable
NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation
Italy100 participantsStarted 2023-03-29
Plain-language 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.
Who can participate
Age range6 Years – 16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1.
Timeframe: Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1).