Long Covid-19NENCANCT06876948
NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation
A study testing Psychological tests, EEG, Magnetic Resonance in people with Long Covid-19, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Long Covid-19
- What is being tested?
- Psychological tests, EEG, Magnetic Resonance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 29 Mar 2023to 28 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Pisana
Pisa, PI, 56126
Vanessa Scacciati, Borsista, 3349349570, vanessa.scacciati@ao-pisa.toscana.it
About this study
Official title: STUDY of NEUROLOGICAL COMPLICATIONS of LONG COVID-19 in CHILDREN and ADOLESCENTS; NEUROPSYCHIATRIC, ELECTROENCEPHALOGRAPHIC and NEURORADIOLOGICAL INVESTIGATIONS
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
- Being tested
- Psychological tests, EEG, Magnetic Resonance
- Keywords
- Covid-19
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological tests, EEG, Magnetic ResonanceDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Psychological tests, EEG, Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start29 Mar 2023
- Primary completion29 Mar 2025 (estimated)
- Study completion28 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alessandro orsini, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876948
- Sponsor's protocol ID
- GR-2021-1237536
- Other IDs
- D65E2000350001
- Acronym
- NENCA
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY of NEUROLOGICAL COMPLICATIONS of LONG COVID-19 in CHILDREN and ADOLESCENTS; NEUROPSYCHIATRIC, ELECTROENCEPHALOGRAPHIC and NEURORADIOLOGICAL INVESTIGATIONS
- ClinicalTrials.gov ID
- NCT06876948
- Acronym / sponsor ID
- NENCA / GR-2021-1237536
- Conditions
- Long Covid-19
- Keywords
- Covid-19
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 29 Mar 2025 (estimated)
- Study completion
- 28 Apr 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Studio NENCA sulle complicanze neurologiche del Long Covid-19 nei bambini e negli adolescenti | Experimental | Diagnostic Test: Psychological tests, EEG, Magnetic ResonancePatients 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological tests, EEG, Magnetic ResonancePatients 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 | Studio NENCA sulle complicanze neurologiche del Long Covid-19 nei bambini e negli adolescenti |
Primary outcome
Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Yes
Related trials for Long Covid-19
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological tests, EEG, Magnetic Resonance in people with Long Covid-19, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Orsini, Dirigente medico (+050 995995, neuropediatriapisa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1. (time frame: Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.