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

STUDY of NEUROLOGICAL COMPLICATIONS of LONG COVID-19 in CHILDREN and ADOLESCENTS; NEUROPSYCHIATRIC, ELECTROENCEPHALOGRAPHIC and NEURORADIOLOGICAL INVESTIGATIONS

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06876948
Acronym
NENCA
Enrollment
100
Registered
2025-03-14
Start date
2023-03-29
Completion date
2026-04-28
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long Covid-19

Keywords

Covid-19

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.

Interventions

DIAGNOSTIC_TESTPsychological 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.

Sponsors

Azienda Ospedaliero, Universitaria Pisana
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1.Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (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.

Countries

Italy

Contacts

Primary ContactAlessandro Orsini, Dirigente medico
neuropediatriapisa@gmail.com+050 995995

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026