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

NCT ID: NCT06876948

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-29
• Study Completion Date: 2026-04-28

Brief 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.

Conditions

Long Covid-19

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Psychological tests, EEG, Magnetic Resonance

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: lead

Responsible Party

alessandro orsini

Alessandro Orsini

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliera Universitaria Pisana

Pisa, PI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessandro Orsini, Dirigente medico

Role: CONTACT

neuropediatriapisa@gmail.com

+050 995995

Facility Contacts

Vanessa Scacciati, Borsista

Role: primary

vanessa.scacciati@ao-pisa.toscana.it

3349349570

Other Identifiers

D65E2000350001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GR-2021-1237536

Identifier Type: -

Identifier Source: org_study_id