Investigating neurological complications of long COVID in children and adolescents
STUDY of NEUROLOGICAL COMPLICATIONS of LONG COVID-19 in CHILDREN and ADOLESCENTS; NEUROPSYCHIATRIC, ELECTROENCEPHALOGRAPHIC and NEURORADIOLOGICAL INVESTIGATIONS
This study is trying to understand how long COVID affects the brains of children and teens aged 6 to 16 by looking at their symptoms and brain activity after they've had the virus.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 6 Years to 16 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero, Universitaria Pisana Academic / other |
| Locations | 1 site (Pisa, PI) |
| Trial ID | NCT06876948 on ClinicalTrials.gov |
What this trial studies
This study focuses on understanding the neurological effects of long COVID-19 in children and adolescents aged 6 to 16 years. It employs neuropsychological assessments, electroencephalography (EEG), and magnetic resonance imaging (MRI) to evaluate the persistence or emergence of neurological symptoms following SARS-CoV-2 infection. The goal is to identify and characterize the neurological complications associated with long COVID in this age group. By gathering data on symptoms such as fatigue, cognitive dysfunction, and mood disorders, the study aims to provide insights into the long-term impacts of COVID-19 on young patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 6 to 16 years who exhibit neurological symptoms consistent with long COVID for at least two months after infection.
Not a fit: Patients who do not have neurological symptoms related to long COVID or those with communication barriers that hinder participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of neurological complications in children and adolescents suffering from long COVID.
How similar studies have performed: While studies on long COVID are emerging, this specific investigation into neurological complications in children and adolescents is relatively novel and may provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pisa, PI
- Azienda Ospedaliera Universitaria Pisana — Pisa, Pi, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro Orsini, Dirigente medico
- Email: neuropediatriapisa@gmail.com
- Phone: +050 995995
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.