NCT06818357

Brief Summary

Epilepsy is a chronic neurological disorder characterized by abnormal neuronal activity, affecting approximately 0.5-1% of children worldwide. It has significant social, psychological, and physical consequences, leading to impairments in cognitive, motor, and behavioral functions. Sensory processing disorders (SPDs) further contribute to these challenges, affecting children's ability to regulate and interpret sensory information, which impacts learning, daily functioning, and emotional regulation. SPDs are categorized into sensory modulation disorder, sensory-based motor disorder, and sensory discrimination disorder. Dunn's sensory processing model identifies four sensory profiles: low registration, sensory seeking, sensory sensitivity, and sensory avoidance. Sensory modulation disorders, including sensory over-responsivity, under-responsivity, and seeking behaviors, can contribute to behavioral and functional difficulties in children with epilepsy. Existing studies on sensory processing in children with epilepsy are limited by small sample sizes and non-comprehensive assessments. This study aims to investigate sensory profiles and perception in a larger sample to enhance early detection and intervention strategies. Objectives: Evaluate sensory perception in children with epilepsy. Examine sensory profiles within this population. The study will include children aged 2-17 years meeting specific criteria. Data collection will involve demographic and epilepsy-related information (seizure onset, frequency, medication, comorbidities). A neurology specialist will assess cerebellar pathology. Sensory processing will be evaluated using the Sensory Processing Measure (SPM), a validated tool assessing sensory processing, balance, body awareness, ideation, and social participation. Based on prior studies, the required sample size is 34 participants. Statistical analyses will be performed using IBM SPSS v.26.0 and R v4.3.0. Normality will be assessed through graphical and statistical tests. Independent samples t-tests, Mann-Whitney U tests, chi-square tests, and correlation analyses will be applied where appropriate. The significance level is set at p\<0.05. This study will contribute to the understanding of sensory perception in children with epilepsy, addressing gaps in the literature and supporting clinical interventions to improve their daily functioning and well-being.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

Same day

First QC Date

February 5, 2025

Last Update Submit

February 9, 2025

Conditions

Keywords

epilepsySensory DisordersPerception Disorders

Outcome Measures

Primary Outcomes (1)

  • Sensory Processing Measure

    Sensory Processing Measure The Sensory Processing Measure (SPM) is designed to assess children aged 5-12 years. It is a standardized caregiver-report tool that evaluates behaviors related to sensory processing, balance, body awareness, ideation, and social participation. Compared to sensory profiles, the SPM assesses different aspects of sensory processing (e.g., perception and discrimination) and their impact on social participation. It is an effective tool for distinguishing sensory processing characteristics between children with different diagnoses and typically developing children. The scale consists of 75 items and includes eight subdomains: Social participation (items 1-10) Vision (items 11-21) Hearing (items 22-29) Touch (items 30-40) Taste/smell (items 41-45) Body awareness (items 46-55) Balance and movement (items 56-66) Planning and ideas (items 67-75) The scale is Likert-type, with response options as follows: 1 (never), 2 (sometimes), 3 (frequently), and 4 (alwa

    1 year

Study Arms (2)

Case group

Children diagnosed with epilepsy

Control group

healthy children

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children diagnosed with epilepsy and healthy children

You may qualify if:

  • Clinical diagnosis of epilepsy Having had an epileptic seizure within the year before the data collection period Being between the ages of 2 and 17 Voluntarily agreeing to participate in the study

You may not qualify if:

  • cerebral palsy, hydrocephalus, autism spectrum disorder, pervasive developmental disorder, learning disability, dyslexia, genetic disease, metabolic disease, neuromuscular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant 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.

MeSH Terms

Conditions

EpilepsySensation Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seda AYAZ TAS, PhD

    Abant Izzet Baysal University

    STUDY DIRECTOR

Central Study Contacts

Seda AYAZ TAS, PhD

CONTACT

Sezen TEZCAN, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 10, 2025

Study Start

March 1, 2025

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations