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
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