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

NCT06876948 | Recruiting

• 2 other identifiers: GR-2021-1237536D65E2000350001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Covid-19

Outcome Measures

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.

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

Study Arms (1)

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

EXPERIMENTAL

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.

Diagnostic Test: Psychological tests, EEG, Magnetic Resonance

Interventions

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.

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

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Pisana

Pisa, PI, 56126, Italy

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Interventions

Electroencephalography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Tomography; Diagnostic Imaging

Central Study Contacts

Alessandro Orsini, Dirigente medico

CONTACT

+050 995995; neuropediatriapisa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alessandro Orsini

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 14, 2025
• Study Start: March 29, 2023
• Primary Completion: March 29, 2025
• Study Completion: April 28, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)