ClinicalTrials.gg
RecruitingNCT06876948NENCAUpdated Mar 14, 2025

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

An interventional study of Psychological tests, EEG, Magnetic Resonance in Long Covid-19, sponsored by Azienda Ospedaliero, Universitaria Pisana. Recruiting at 1 site in Italy. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by Azienda Ospedaliero, Universitaria Pisana · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 10 months after the study started (first participant enrolled Mar 2023, registered Feb 2025).
  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
6 Years to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Long Covid-19

Keywords

  • Covid-19
03

In context

Post-Acute COVID-19 Syndrome

604 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 201 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 416 interventional studies indexed under Post-Acute COVID-19 Syndrome.

Browse Post-Acute COVID-19 Syndrome studies →

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana is the lead sponsor of 57 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 by caregiver(s) and patient(s)

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    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.

    Diagnostic Test: Psychological tests, EEG, Magnetic Resonance

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.

06

What researchers measure

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).

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Mar 2025, 24 months after the start.

Of 233 non-industry interventional studies with no phase under Post-Acute COVID-19 Syndrome, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 28. This study's planned 24 months is above that.

Counting every sponsor, half of 244 studies reached it within 16 months; a quarter within 7 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2025
First posted
Mar 14, 2025
StartActual
Mar 29, 2023
Primary completionEst.
Mar 29, 2025
CompletionEst.
Apr 28, 2026
Last update
Mar 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06876948
Lead sponsor
Azienda Ospedaliero, Universitaria Pisana
Responsible party
alessandro orsini (Alessandro Orsini, Azienda Ospedaliero, Universitaria Pisana) — Principal investigator
First posted
Mar 14, 2025
Start date
Mar 29, 2023
Primary completion
Mar 29, 2025 (estimated)
Completion
Apr 28, 2026 (estimated)
Last update
Mar 14, 2025

Study contacts

Alessandro Orsini, Dirigente medico
Contact
neuropediatriapisa@gmail.com
+050 995995

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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