AzTrials
AzTrials

EpilepsyNCT06818357

Sensory Perception in Children With Epilepsy

An observational study of Epilepsy and Sensory Disorders, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Epilepsy, Sensory Disorders, Perception Disorders
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2025to 1 Mar 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Children diagnosed with epilepsy and healthy children

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Seda AYAZ TAS, PhD contact

+905495458040

seda.ayaztas@ibu.edu.tr

Sezen TEZCAN, PhD contact

+905445723731

sezentezcan@ibu.edu.tr

Turkey (Türkiye)1 site
  • Abant Izzet Baysal University

    Bolu

    Seda AYAZ TAS, PhD, +905495458040, seda.ayaztas@ibu.edu.tr

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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.

Read the detailed description

Epilepsy is a transient condition that occurs due to abnormal high neuronal activity or asynchronous neuronal circuits in the brain and is defined as such by the International League Against Epilepsy (ILAE). Epilepsy is one of the most common chronic childhood diseases, affecting approximately 0.5-1% of children worldwide. According to the relevant literature, an estimated 10.5 million children under the age of 15 are currently diagnosed with active epilepsy. Epilepsy is classified based on clinical characteristics such as seizure type, age of onset, cognitive and developmental history, presence of neurological symptoms, family history, electroencephalography findings, seizure triggers, seizure occurrence during sleep, and prognosis.

Seizures in children with epilepsy have profound negative effects on social, psychological, and physical health, leading to impairments in cognitive functioning. Various studies have reported potential deficits in intelligence, memory, learning, attention, motor skills, and behavioral abilities in children with epilepsy. Additionally, deficits in executive functions and motor coordination, along with difficulties in responding to environmental demands, have been reported.

Beyond epilepsy, sensory processing disorders significantly impact children's ability to process, regulate, and interpret sensory information from the environment. These disorders affect cognitive, motor, behavioral, and emotional responses. Sensory processing disorders are commonly associated with impairments in neuropsychomotor development. Children experiencing these difficulties may exhibit behavioral issues, sleep disorders, social interaction challenges, and aggression. Additionally, heightened emotional reactions and frequent crying are commonly observed behavioral traits. Sensory processing disorders can negatively affect self-regulation, learning, functional behaviors, daily living skills, motor organization, and school performance.

Sensory processing disorders are typically classified into three main categories: sensory modulation disorder, sensory-based motor disorder, and sensory discrimination disorder. According to Dunn's sensory processing theory, individuals' responses to sensory stimuli vary based on their neurological threshold levels and their type of response to stimuli. Dunn describes a continuous interaction in which individuals' responses to sensory stimuli may lead to maladaptive behaviors. Dunn classifies these responses into passive and active self-regulation strategies. Passive self-regulation allows individuals to experience sensory stimuli without controlling them, whereas active self-regulation involves controlling and modulating stimuli. Based on these mechanisms, four distinct sensory profiles are defined: low registration, sensory seeking, sensory sensitivity, and sensory avoidance.

Low registration refers to a high neurological threshold, resulting in individuals not noticing sensory stimuli or responding very slowly. Sensory seeking describes individuals with a high neurological threshold who actively seek excessive sensory input. In this case, individuals may be drawn to strong stimuli such as intense smells, sounds, or lights. Sensory sensitivity is characterized by a low sensory threshold, where individuals exhibit heightened sensitivity to environmental stimuli but do not generate an active response. Sensory avoidance, also associated with a low sensory threshold, involves active strategies to avoid distressing stimuli.

Sensory modulation disorders involve difficulties in detecting, regulating, and interpreting sensory stimuli or in generating appropriate responses to them. In the literature, sensory modulation disorders are classified into three main categories: sensory over-responsivity, sensory under-responsivity, and sensory seeking. These disorders may lead to behavioral problems due to an inability to regulate responses to environmental sensory stimuli.

Studies conducted on children with epilepsy have generally focused on small sample sizes and specific epilepsy types, using short-form sensory profile assessments. Moreover, most of these studies have included a limited number of participants. Despite these limitations, existing research highlights the need for further investigation into the prevalence and effects of sensory modulation and perception disorders in children with epilepsy.

The aim of this study is to investigate the sensory profiles of children with epilepsy in a larger sample and identify the presence of sensory perception disorders in this population. By doing so, this study aims to improve the understanding of sensory processing disorders in children with epilepsy and contribute to the development of effective early detection methods. This research will facilitate a more detailed identification of sensory perception disorders among children with epilepsy, addressing gaps in the literature and supporting necessary interventions to enhance their daily living skills and overall health.

Objectives:

To evaluate sensory perception in children with epilepsy.

To examine the sensory profiles of children with epilepsy.

If significant results are obtained, these findings are intended to contribute to clinical practice and scientific research. The study will be conducted with children aged 2-17 years who meet the inclusion criteria and whose families voluntarily agree to participate. During the study period, eligible children will be assessed according to inclusion criteria. Detailed demographic information and epilepsy-related characteristics will be collected, including the age of seizure onset, seizure frequency, medications used, comorbid conditions, and family psychiatric history. A neurology specialist will assess the presence of cerebellar pathology in the participating children. Sensory perception will be evaluated using the 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 (always). The Turkish validity and reliability study of the scale was conducted by Özbakır.

A literature review revealed that no direct studies have examined sensory perception in this specific population. However, previous studies have suggested that sensory perception and sensory modulation may yield similar results. Based on this, a study measuring sensory perception was considered. In that study, a large effect size (d=1.31) was observed between patient and control groups. Using this effect size, the required sample size was calculated for an independent samples t-test with 90% power and a 5% error rate. The analysis determined that at least 14 participants per group (a total of 28) were necessary. Assuming a 20% attrition rate, the final target sample size was set at a minimum of 34 participants (17 per group). The calculation was performed using G-Power 3.1.9.7 software.

Statistical analyses will be conducted using IBM SPSS Statistics v.26.0 (Armonk, NY: IBM) and R Statistical Software (v4.3.0; R Core Team 2023). Descriptive statistics will be reported as means and standard deviations for numerical data, or quartiles where applicable, and as counts and percentages for categorical data. Normality assumptions will be checked using graphical methods (QQ plots, histograms) and hypothesis tests (Shapiro-Wilk test). Independent samples t-tests will be used for comparing numerical variables between groups when assumptions are met; otherwise, the Mann-Whitney U test will be applied. Categorical variable comparisons will be conducted using chi-square tests (Pearson, Yates, Fisher's Exact Test). Correlations between numerical variables will be analyzed using Pearson or Spearman correlation coefficients depending on assumption fulfillment. The significance level is set at p<0.05.

Keywords
epilepsy, Sensory Disorders, Perception Disorders
Medical subject headings
Epilepsy, Sensation Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06818357
Study groupRoleWhat they receive
Case groupChildren diagnosed with epilepsy
Control grouphealthy children

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06818357
Sponsor's protocol ID
BAIBU-FTR-SAT-8
Status last verified
Feb 2025
First submitted
5 Feb 2025
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26504494

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy and Sensory Disorders, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seda AYAZ TAS, PhD (+905495458040, seda.ayaztas@ibu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensory Processing Measure (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06818357, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in