NCT07588971

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Oct 2021Jun 2027

Study Start

First participant enrolled

October 26, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2023

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

5.2 years

First QC Date

March 2, 2023

Last Update Submit

May 11, 2026

Conditions

Pediatric Epilepsies

Keywords

Pediatric EpilepsiesEpilepsiesPediatric Neuropsychiatry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Seizure outcome

    24 months after entry visit

  • QOLIE-31

    24 months after entry visit

  • Clinical Global Impression Scale

    24 months after entry visit

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Domenica Immacolata Battaglia

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenica Immacolata Battaglia, MD

CONTACT

+39 0630159222domenicaimmacolata.battaglia@policlinicogemelli.it

Michela Quintiliani, MD

CONTACT

+39 0630159222michela.quintiliani@guest.policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

March 2, 2023

First Posted

May 15, 2026

Study Start

October 26, 2021

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations

IT(1)