An observational study in Epilepsy (treatment Refractory), sponsored by Ana Valeria Duarte Oliveira. Completed at 1 site in Brazil. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Ana Valeria Duarte Oliveira · Observational
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.
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 369 is above the median of 102 across 521 observational studies indexed under Epilepsy.
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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.
Exclusion Criteria:
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.
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"
Determinants of Changes in Adaptive Scores through the Vineland Scale in Pediatric Patients with Drug-Resistant Epilepsy
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.
Time frame: "From enrollment to the end of treatment at 48 months"
Plan to share: Yes — A description of the complete protocol study will be provided so that the fases can be fully interpreted.
Supporting information: Study protocol
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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