Natural History and Prognosis of Pediatric Epilepsies With Different Etiology

Natural History and Prognosis of Pediatric Epilepsies With Different Etiology: Long-term Study

Epilepsy is one of the most common neurological diseases in Italy, affecting about 500,000 people. Pediatric age represents one of the most affected groups with a consequent significant impact on the quality of life of the families involved.

The study aims to monitor the cognitive functions of patients followed at our center in order to determine the main types of pathways and highlight their determinants. The ultimate goal is to define what are the main clinical and instrumental predictors of cognitive function and its variation over time.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Epilepsies

• Study Type: Observational
• Enrollment (Estimated): 2300

Contacts and Locations

• Study Contact: Name: domenica Immacolata Battaglia, MD; Phone Number: +39 0630159222; Email: domenicaimmacolata.battaglia@policlinicogemelli.it
• Study Contact Backup: Name: Michela Quintiliani, MD; Phone Number: +39 0630159222; Email: michela.quintiliani@guest.policlinicogemelli.it

Study Locations

• Italy
  • Rome, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: domenica Immacolata Battaglia, MD; Phone Number: +39 0630159222; Email: domenicaimmacolata.battaglia@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

People with epilepsy seen at the Children's Neuropsychiatry of the Fondazione Policlinico Gemelli IRCCS (UOS Diagnosis and Treatment of Drug-Resistant Epilepsies, Day Hospital or inpatient setting at the Department of Children's Neuropsychiatry). Epilepsy is defined according to 2014 ILAE criteria: (1) at least two unprovoked (or reflex) seizures occurring more than 24 h apart; (2) one unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 years; (3) diagnosis of an epilepsy syndrome.

Description

Inclusion Criteria:

• Patients seen at the Children's Neuropsychiatry of the Fondazione Policlinico Gemelli IRCCS (UOS Diagnosis and Treatment of Drug-Resistant Epilepsies, Day Hospital or inpatient setting at the Department of Children's Neuropsychiatry) with onset of first seizure between the ages of 0 and 18 years and subsequent diagnostic confirmation of epilepsy (2 or more unprovoked seizures at least 24 hours apart or definite epilepsy syndrome, with diagnostic confirmation by the child neuropsychiatrist).
• Patients already followed at Child Neuropsychiatry with a diagnosis of epilepsy with age of onset between 0 and 18 years.
• Patients referred to our Center during follow-up with a diagnosis of epilepsy with age of onset between 0 and 18 years.

Exclusion Criteria:

• Patients with unconfirmed diagnosis of epilepsy after the first critical episode.
• Patients from other Centers, for whom the history, clinical and instrumental data are not sufficiently detailed and in accordance with the methodologies followed at our Center.
• Patients with follow-up < 2 years.
• Patients for whom study consent is not provided.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurodevelopment level	Evaluate prescholar global development and scholar cognitive level with Griffiths or Weschler scales where applicable according to age.	12 months after entry visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure outcome	Evaluate the reduction in seizures (percentage)	24 months after entry visit
QOLIE-31	Evaluate the Impact of the Epilepsy on the quality of life	24 months after entry visit
Clinical Global Impression Scale	Evaluate the global clinical impression to have a measure of epilepsy severity and the burden of antiseizure medication on daily life.	24 months after entry visit

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Domenica Immacolata Battaglia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Epilepsies; Pediatric Epilepsies; Pediatric Neuropsychiatry
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 3971

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No