Determinants of Adaptive Behavior Through the Vineland Scale in Pediatric Patients with Severe and Drug-resistant Epilepsy

February 12, 2025 updated by: Ana Valeria Duarte Oliveira

Avaliação Do Desenvolvimento Adaptativo a Longo Prazo Após a Cirurgia De Epilepsia Em Crianças E Adolescentes Farmacorresistentes

Our interest in studying how pediatric patients develop after epilepsy surgery stems from the fact that difficult-to-control epilepsy causes changes in the brain's formation or functioning, leading some patients to experience slower development compared to others. By gaining a better understanding of how pediatrics patients fare after epilepsy surgery, specifically regarding their independence in daily activities (such as bathing or making the bed), their relationships with family and friends, their mobility, and their speech (whether it is understandable) we can learn more about patient recovery. The goal of this research is to determine whether, 4 years after epilepsy surgery, pediatrics patients show improvements in development. This study is important because it investigates what happens to the development of children who have undergone epilepsy surgery after a long period has passed since the procedure. Research focusing on long-term post-surgical outcomes is necessary, especially in pediatrics, as a brain is not fully developed and requires time to recover after surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

Participation in the study was voluntary, and refusal to participate or withdrawal of consent at any of the three phases of the research did not result in any penalties. We are committed to maintaining the confidentiality of your child's data, and they were not identified. The data related to the clinical information for the purposes of this research were processed and stored in a database at the Epilepsy Surgery Center (CIREP) of the Hospital das Clínicas de Ribeirão Preto, where only the researchers had access via password. These data will be used for research purposes to assist in the planning of therapeutic intervention.

Once the inclusion in this study was identified and confirmed, the data of all patients were analyzed through a review of electronic medical records and the SAME (Medical and Statistical Archive Service) of HCFMRP-USP. The information obtained was stored in an SPSS database and subsequently analyzed. The following variables were collected: sex, age, age at pre- and postoperative neuropsychological assessment, Engel classification, type of surgery, resection, pathology, seizure frequency, dates of assessments, MRI reports, and findings from the Vineland scale related to communication, socialization, daily living skills, motor skills, and conclusions. Only the principal investigator was authorized to handle the database, in accordance with the data protection and confidentiality standards for the information collected from the patients' electronic medical records included in the study.

This study was classified as an observational retrospective cohort analysis. A total of 369 patients with chronological age ranging from 0 to 18 years and severe epilepsy that was unresponsive to drug therapy (defined as uncontrolled epilepsy despite the use of one or two combined drugs) were referred to the study. The patients were divided into two groups: a control group consisting of 204 patients without an established epileptogenic focus, and a clinical group comprising 165 patients with a diagnosed epilepsy, both groups, treated at the Ribeirão Preto Epilepsy Surgery Program (CIREP) of the Clinical Hospital of Ribeirão Preto - University of São Paulo (HCFMRP-USP) between 1996 and 2019.

The statistical analyses were conducted using the IBM SPSS 23.0 for Windows software (Statistical Package for Social Sciences, SPSS Inc., 1989-2004, Chicago, IL, USA). The variables were assessed for normality using the Kolmogorov-Smirnov test. Categorical variables were summarized using frequency counts, relative frequencies, and valid percentages. Continuous variables were presented as means and standard deviations, along with minimum and maximum values, median, and interquartile range. Univariate analysis was undertaken using post hoc Tukey to examine potential etiological differences between-subjects. Statistical analyses were performed using Pearson's correlation test, and multiple linear regression were conducted to identify neurologic predictors of adaptive function. A significance level of 0.05 or less was considered as the threshold for statistical significance.

The sample size was calculated using the G*Power 3.1.9.7 for Windows program (2020). We used Fisher's exact test, where the test power was set to 0.8, and the error probability was set to 0.05, indicating that the ideal total sample size would be 88 patients, distributed in two equally sized groups. We chose to conduct the study with all patients in the CIREP database, resulting in a sample composed of 369 pediatric patients.

Study Type

Observational

Enrollment (Actual)

369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14.048-900
        • Center for Pediatric Epilepsy Surgery, University Hospital, Ribeirão Preto Medical School, University of São Paulo, Brazil.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study was classified as an observational retrospective cohort analysis. A total of 369 patients with chronological age ranging from 0 to 18 years and severe epilepsy that was unresponsive to drug therapy (defined as uncontrolled epilepsy despite the use of one or two combined drugs) were referred to the study. The patients were divided into two groups: a control group consisting of 204 patients without an established epileptogenic focus, and a clinical group comprising 165 patients with a diagnosed epilepsy, both groups, treated at the Ribeirão Preto Epilepsy Surgery Program (CIREP) of the Clinical Hospital of Ribeirão Preto - University of São Paulo (HCFMRP-USP) between 1996 and 2019.

Description

Inclusion Criteria:

  • Chronological age ranging from 0 to 18 years
  • Severe epilepsy that was unresponsive to drug therapy (defined as uncontrolled epilepsy despite the use of one or two combined drugs) were referred to the study.

Exclusion Criteria:

  • Involved patients whose parents or responsible relatives had psychiatric disorders
  • Patients who were unable to complete the neuropsychological assessment questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group consisting of 204 patients and clinical group comprising 165 patients.
The patients were divided into two groups: a control group consisting of 204 patients without an established epileptogenic focus, and a clinical group comprising 165 patients with a diagnosed epilepsy, both groups, treated at the Ribeirão Preto Epilepsy Surgery Program (CIREP) of the Clinical Hospital of Ribeirão Preto - University of São Paulo (HCFMRP-USP) between 1996 and 2019.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determinants of Changes in Adaptive Scores through the Vineland Scale in Pediatric Patients with Drug-Resistant Epilepsy
Time Frame: "From enrollment to the end of treatment at 48 months"
"From enrollment to the end of treatment at 48 months"
Determinants of Changes in Adaptive Scores through the Vineland Scale in Pediatric Patients with Drug-Resistant Epilepsy
Time Frame: "From enrollment to the end of treatment at 48 months"

In a retrospective study, our objective was to assess the clinical condition of the patients through data such as Vineland Adaptive Behavior Scales (VABS) in pediatric patients with severe, difficult-to-control epilepsy. The VABS assesses various domains, including communication, daily living skills, socialization, and motor skills. The assessments were conducted in a blinded manner to avoid contaminating the data collection and results with any information obtained prior to the completion of the questionnaire.

Regarding the performance of a given activity, a score of 2 indicates "yes, normally," 1 "sometimes or partially," and 0 "no, never." The 'N' scores indicate that the individual "has no opportunity" to perform the activity, and 'D' indicates "unknown," meaning the caregiver or responsible person does not know whether the patient performs the activity. The higher the score, the better the adaptive outcome the patients.
"From enrollment to the end of treatment at 48 months"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ana Valeria Duarte Oliveira

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

  • Study Director: Tonicarlo R Velasco, Doctor, Center for Pediatric Epilepsy Surgery, University Hospital, Ribeirão Preto Medical School, University of São Paulo, Brazil.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Actual)

January 18, 2023

Study Completion (Actual)

July 11, 2023

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.829.087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A description of the complete protocol study will be provided so that the fases can be fully interpreted.

IPD Sharing Time Frame

Beginning December 2025 and ending 2 years after the publication of results.

IPD Sharing Access Criteria

The data related to this article will be available for public access through a link to the chosen academic journal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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