Clinical trial NCT03806946: Impact of Relationship of Epilepsy and Attention Deficit Hyperactive Disorder
Official title: Impact of Relationship of Epilepsy and Attention Deficit Hyperactive Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention-Deficit Hyperactivity Disorder
Epilepsy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: childern and adolescent attending psychiatric outpatients clinic of Assiut university who had diagnosis of attention deficit hyperactivity disorder or epilepsy or both and with age (6y-11y)

Brief summary: The most common neuropsychiatric disorder in early childhood is attention deficit/hyperactivity disorder (ADHD) with evidence of abnormality in structure and function of brain. Epilepsy is one of the commonest comorbidity associated with ADHD with negative outcome on childrens' quality of life, and is considered to be a risk for academic underachievement. These two disorders are highly associated, with more possibility to be a bidirectional relationship. The mechanisms of this comorbidity are unknown. In this association, a difficult challenge is presented since antiepileptic therapy and drugs used to treat ADHD may aggravate the clinical picture of each other. The main objectives are to evaluate this overlap of those disorders, find their complications on child and his family, and to suggest possible solutions to improve the outcome of those children.

Detailed description: The commonest childhood disorder is attention deficit hyperactivity disorder(ADHD) which continues into adulthood.The main two symptoms are inattention and hyperactivity.

As epilepsy is one of the commonest comorbidity with ADHD to about (40%), there are many overlap symptoms between both disorders for example:

* Behavioral features which are shared in both frontal lobe epilepsy with ADHD such as impulsivity, disinhibition, and irritability
* The electroencephalogram: there is an increase in the rate of spikes in children with ADHD with no epileptic symptoms, which supports the theory of presence similar mechanism about central nervous system dysfunction.

These reasons lead to increase obstacles for diagnosis, assessment, and treatment for both disorders.

As this comorbidity duplicates the complications (i.e. drop the school, financial cost, stress on families, negative effect on academic, vocational, social relations and self-esteem ) so there is a great need to study this comorbidity to give a proper care for these patients.

In this study, all participants will be enrolled over a period of 12 months from Assiut outpatients clinic .All participants will be assessed in the psychiatric interview by using prepared child and adolescent psychiatric sheet include (psychiatric and neurology history, physical examination and mental state examination). After that electroencephalogram(EEG) will be done to diagnoses epilepsy and identify different types of seizures.

All participants will be categorizing into 4 groups ( ADHD, epilepsy, ADHD,and epilepsy, healthy) according to EEG and the psychiatric sheet. Each group will be assessed by different psychometrics scales to evaluate cognitive, social, economic and behavioral outcome. The results of all groups will be analysed by using Stata version 15 to evaluate the effect of ADHD and epilepsy in children and adolescent and identify the possible risk factors to improve outcome

Eligibility criteria: Inclusion Criteria:

* Both males and females were included.
* Age range from 6- 11 years.
* Diagnosis of ADHD and/or epilepsy was verified and confirmed either on a clinical basis or by using reliable psychometric tests.
* In epilepsy groups: only Idiopathic type was included.
* Willing of the parents or the caregivers to participate in the study.

Exclusion Criteria:

* Children whom caretakers refused to give informed consent.
* Children with intelligence quotient below 70.
* Children with history or current substance use.
* Children with medical or other neurological conditions.

Primary outcomes:
measure: measure intellectual equations for children with epilepsy and ADHD
timeFrame: baseline
measure: measure socioeconomic class for families and children with comorbid epilepsy and ADHD
timeFrame: baseline
measure: measure mood and feeling changes in children with comorbid epilepsy and ADHD.
timeFrame: baseline
measure: measure quality of life for children with comorbid epilepsy and ADHD
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Alaa El-Din Darweesh, PhD
role: STUDY_DIRECTOR
affiliation: Assiut University
name: HossamEddin Ahmad, PhD
role: STUDY_CHAIR
affiliation: King's College London
name: Patrick Bolton, PhD
role: STUDY_CHAIR
References:
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citation: Kanner AM. The use of psychotropic drugs in epilepsy: what every neurologist should know. Semin Neurol. 2008 Jul;28(3):379-88. doi: 10.1055/s-2008-1079342. Epub 2008 Jul 24.
citation: Chou IC, Chang YT, Chin ZN, Muo CH, Sung FC, Kuo HT, Tsai CH, Kao CH. Correlation between epilepsy and attention deficit hyperactivity disorder: a population-based cohort study. PLoS One. 2013;8(3):e57926. doi: 10.1371/journal.pone.0057926. Epub 2013 Mar 6.
citation: Sherman EM, Slick DJ, Connolly MB, Eyrl KL. ADHD, neurological correlates and health-related quality of life in severe pediatric epilepsy. Epilepsia. 2007 Jun;48(6):1083-91. doi: 10.1111/j.1528-1167.2007.01028.x. Epub 2007 Mar 22.
citation: Kaufmann R, Goldberg-Stern H, Shuper A. Attention-deficit disorders and epilepsy in childhood: incidence, causative relations and treatment possibilities. J Child Neurol. 2009 Jun;24(6):727-33. doi: 10.1177/0883073808330165.
citation: Kirov R, Kinkelbur J, Banaschewski T, Rothenberger A. Sleep patterns in children with attention-deficit/hyperactivity disorder, tic disorder, and comorbidity. J Child Psychol Psychiatry. 2007 Jun;48(6):561-70. doi: 10.1111/j.1469-7610.2007.01729.x.
citation: Dickstein, L.J., Roba, M.B. and Oldham, J.M.(1997): Review of psychiatry. AmericanPsychiatric Press. Washington, DC. London,England.
citation: Ahmed GK, Darwish AM, Khalifa H, Khashbah MA. Evaluation of psychiatric comorbidity in attention-deficit hyperactivity disorder with epilepsy: A case-control study. Epilepsy Res. 2021 Jan;169:106505. doi: 10.1016/j.eplepsyres.2020.106505. Epub 2020 Nov 21.