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).
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.
Turkey (Türkiye)1 site
Abant Izzet Baysal University
Bolu
Seda AYAZ TAS, PhD, +905495458040, seda.ayaztas@ibu.edu.tr
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.
- Conditions
- Epilepsy, Sensory Disorders, Perception Disorders
- 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 group | Role | What they receive |
|---|---|---|
| Case group | Children diagnosed with epilepsy | |
| Control group | healthy children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted10 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda AYAZ TAŞ, Abant Izzet Baysal University
- Investigators
- Seda AYAZ TAS, PhD, Study director, Abant Izzet Baysal University
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Perception in Children With Epilepsy
- ClinicalTrials.gov ID
- NCT06818357
- Acronym / sponsor ID
- BAIBU-FTR-SAT-8
- Conditions
- Epilepsy, Sensory Disorders, Perception Disorders
- Keywords
- epilepsy, Sensory Disorders, Perception Disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –Children diagnosed with epilepsy |
| Control group | – | –healthy children |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children diagnosed with epilepsy and healthy children
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- cerebral palsy, hydrocephalus, autism spectrum disorder, pervasive developmental disorder, learning disability, dyslexia, genetic disease, metabolic disease, neuromuscular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory Processing Measure
Time frame: 1 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Results publication: PubMed 26504494van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seda AYAZ TAS, PhD study director
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
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.