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

ConditionLong Covid-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-16
SponsorAzienda Ospedaliero, Universitaria Pisana

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Psychological tests, EEG, Magnetic Resonance

    Diagnostic test

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Studio NENCA sulle complicanze neurologiche del Long Covid-19 nei bambini e negli adolescentiExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1.

Assessment of cognitive, neuropsychological and adaptive skills in children and adolescents with Long COVID by means of standardised tests (WISC-IV, CPT3, NEPSY II, BRIEF-2, Vineland Adaptive Behavior Scales). The tests measure attention, memory, executive functions, intellectual-adaptive functioning and quality of life.

Time frame
Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1).

Secondary outcomes

Other outcomes

Sponsors and contacts

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