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

Azienda Ospedaliero, Universitaria Pisana

Status: Enrolling

Conditions: Long Covid-19

Treatments: Diagnostic Test: Psychological tests, EEG, Magnetic Resonance

Study type: Interventional

Funder types: Other

Identifiers

NCT06876948

GR-2021-1237536

D65E2000350001 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Studio NENCA sulle complicanze neurologiche del Long Covid-19 nei bambini e negli adolescenti

Experimental group

Description:

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:

Diagnostic Test: Psychological tests, EEG, Magnetic Resonance