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

NCT06832020 | Completed DMC

• 1 other identifier: 4.829.087
• Study Type: observational
• Target: 369
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy (treatment Refractory)

Keywords

Epilepsy Drug-resistant. Epilepsy Surgery. Vineland. Pediatrics patients

Outcome Measures

Primary Outcomes (2)

• Determinants of Changes in Adaptive Scores through the Vineland Scale in Pediatric Patients with Drug-Resistant Epilepsy

  "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.

  "From enrollment to the end of treatment at 48 months"

Study Arms (1)

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.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ana Valeria Duarte Oliveira: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14.048-900, Brazil

Location

Related Publications (8)

• Vendrame M, Alexopoulos AV, Boyer K, Gregas M, Haut J, Lineweaver T, Wyllie E, Loddenkemper T. Longer duration of epilepsy and earlier age at epilepsy onset correlate with impaired cognitive development in infancy. Epilepsy Behav. 2009 Nov;16(3):431-5. doi: 10.1016/j.yebeh.2009.08.008. Epub 2009 Sep 19.

  PMID: 19767243 BACKGROUND

• Nolan MA, Redoblado MA, Lah S, Sabaz M, Lawson JA, Cunningham AM, Bleasel AF, Bye AM. Intelligence in childhood epilepsy syndromes. Epilepsy Res. 2003 Feb;53(1-2):139-50. doi: 10.1016/s0920-1211(02)00261-9.

  PMID: 12576175 BACKGROUND

• Loring DW, Meador KJ. Cognitive side effects of antiepileptic drugs in children. Neurology. 2004 Mar 23;62(6):872-7. doi: 10.1212/01.wnl.0000115653.82763.07.

  PMID: 15037684 BACKGROUND

• Pulsifer MB, Brandt J, Salorio CF, Vining EP, Carson BS, Freeman JM. The cognitive outcome of hemispherectomy in 71 children. Epilepsia. 2004 Mar;45(3):243-54. doi: 10.1111/j.0013-9580.2004.15303.x.

  PMID: 15009226 BACKGROUND

• Howell KB, Harvey AS, Archer JS. Epileptic encephalopathy: Use and misuse of a clinically and conceptually important concept. Epilepsia. 2016 Mar;57(3):343-7. doi: 10.1111/epi.13306. Epub 2016 Jan 18.

  PMID: 26778176 BACKGROUND

• Fisher RS, Cross JH, D'Souza C, French JA, Haut SR, Higurashi N, Hirsch E, Jansen FE, Lagae L, Moshe SL, Peltola J, Roulet Perez E, Scheffer IE, Schulze-Bonhage A, Somerville E, Sperling M, Yacubian EM, Zuberi SM. Instruction manual for the ILAE 2017 operational classification of seizure types. Epilepsia. 2017 Apr;58(4):531-542. doi: 10.1111/epi.13671. Epub 2017 Mar 8.

  PMID: 28276064 BACKGROUND

• Gaillard WD, Chiron C, Cross JH, Harvey AS, Kuzniecky R, Hertz-Pannier L, Vezina LG; ILAE, Committee for Neuroimaging, Subcommittee for Pediatric. Guidelines for imaging infants and children with recent-onset epilepsy. Epilepsia. 2009 Sep;50(9):2147-53. doi: 10.1111/j.1528-1167.2009.02075.x. Epub 2009 Apr 6.

  PMID: 19389145 BACKGROUND

• D'Argenzio L, Colonnelli MC, Harrison S, Jacques TS, Harkness W, Vargha-Khadem F, Scott RC, Cross JH. Cognitive outcome after extratemporal epilepsy surgery in childhood. Epilepsia. 2011 Nov;52(11):1966-72. doi: 10.1111/j.1528-1167.2011.03272.x.

  PMID: 22032791 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tonicarlo R Velasco, Doctor

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Neurology

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: February 18, 2025
• Study Start: July 7, 2021
• Primary Completion: January 18, 2023
• Study Completion: July 11, 2023
• Last Updated: February 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning December 2025 and ending 2 years after the publication of results.
• Access Criteria: The data related to this article will be available for public access through a link to the chosen academic journal.

Locations

BR (1)