Sensory Modulation in Children With Epilepsy

NCT06818344 | Not Yet Recruiting

• 1 other identifier: BAIBU-FTR-SAT-7
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy is a neurological condition that can impact cognitive, motor, and behavioral skills, often leading to sensory modulation disorders (SMDs) in children. These disorders impair sensory processing, affecting daily functioning and quality of life. This study aims to explore the sensory profiles of children with epilepsy and identify sensory modulation disorders. The study will include 34 participants: 17 children with epilepsy and 17 healthy controls, aged 3-10 years. Inclusion criteria include at least one seizure in the past year, a diagnosis of epilepsy, and voluntary participation. Children with comorbid conditions such as cerebral palsy, autism, genetic disorders, or other neurological conditions will be excluded. Data on demographics and epilepsy-related characteristics will be gathered from families. Sensory modulation will be assessed using the Sensory Profile, a 125-item Likert-type questionnaire completed by parents. It evaluates sensory processing across three categories: sensory processing, sensory modulation, and behavioral-emotional responses. Results will classify children as "Typical Performance," "Probable Difference," or "Definite Difference." Data will be analyzed using IBM SPSS 26.0 and R Software. The Shapiro-Wilk test will assess normality, followed by an Independent Samples t-test or Mann-Whitney U Test depending on data distribution. The Chi-Square test will be used for categorical variables. This study aims to identify the prevalence and types of sensory modulation disorders in children with epilepsy. While previous studies suggest sensory processing issues in children with epilepsy, they often involve small samples. By using a larger sample, this research will provide stronger insights into the sensory profiles of children with epilepsy. The findings may contribute to earlier diagnosis and intervention strategies. Future research should involve larger samples and longitudinal designs to investigate long-term effects and therapeutic approaches for sensory modulation disorders, ultimately improving the quality of life for children with epilepsy.

Conditions

Epilepsy; Sensory Modulation Disorder

Keywords

epilepsy; sensory modulation; child

Outcome Measures

Primary Outcomes (1)

• Sensory Profile

  The Sensory Profile, developed by Winnie Dunn, is a 125-item Likert-type questionnaire used to assess how children aged 3-10 process sensory information from their bodies and environment. It is divided into three main sections: Sensory Processing, Modulation, and Behavioral and Emotional Responses. Sensory Processing includes subcategories such as auditory, visual, vestibular, tactile, multisensory, and oral processing. Modulation evaluates sensory processing related to endurance, movement, and body position, as well as the regulation of sensory inputs affecting emotional responses. Behavioral and Emotional Responses assess emotional, social responses, and behavioral consequences. Each section is scored based on frequency, and children are classified as having "typical performance," "probable difference," or "definite difference," based on the results. The test is widely used to evaluate sensory processing disorders in children.

  1 year

Study Arms (2)

case group

Children diagnosed with epilepsy constitute the "case group." Sensory modulation assessments will be conducted for the children in this group.

Control group

The control group consists of healthy children. The same assessment will be applied to this group as well.

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 3-10 years diagnosed with epilepsy and healthy children.

You may qualify if:

• Having had a seizure in the year prior to data collection Clinical diagnosis of epilepsy Aged between 3 and 10 years Willing to participate in the study

You may not qualify if:

• Diagnosis of cerebral palsy Diagnosis of hydrocephalus Diagnosis of autism spectrum disorder Diagnosis of pervasive developmental disorder Diagnosis of learning disabilities Diagnosis of dyslexia Diagnosis of genetic disorders Diagnosis of metabolic disorders Diagnosis of neuromuscular diseases

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Izzet Baysal University

Bolu, Turkey (Türkiye)

Location

Related Publications (1)

• van Campen JS, Jansen FE, Kleinrensink NJ, Joels M, Braun KP, Bruining H. Sensory modulation disorders in childhood epilepsy. J Neurodev Disord. 2015;7:34. doi: 10.1186/s11689-015-9130-9. Epub 2015 Oct 23.

  PMID: 26504494 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Seda AYAZ TAS, PhD

  Abant Izzet Baysal University

  STUDY DIRECTOR

Central Study Contacts

Seda AYAZ TAS, PhD

CONTACT

+905495458040; seda.ayaztas@ibu.edu.tr

Sezen TEZCAN, PhD

CONTACT

sezentezcan@ibu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Dr.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

TU (1)