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Completed

NCT Number: NCT03806946

Impact of Relationship of Epilepsy and Attention Deficit Hyperactive Disorder

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.

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Key information

Conditions

Attention-Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Brain Diseases Central Nervous System Diseases Epilepsy Mental Disorders Nervous System Diseases Neurodevelopmental Disorders

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University Hospital

Asyut, 71111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroencephalography

Diagnostic Test

diagnosis epileptic discharge

Other names: EEG

psychometric scales to diagnosis psychiatric disorders

Diagnostic Test

to diagnosis intellectual disability, attention deficit hyperactivity disorder ,epilepsy,autism and other mental illness.

Other names: WISC III (Wechsler Intelligence Scale for Children),conners 3rd Edition,(cbcl)The Child Behavior Checklis,Epilepsy interview,The Childhood Autism Spectrum Test (CAST)

psychometric scales for assesment socioeconomic and behaviour problems

Other

to assessment other behavioural comorbidity as aggression ,mood changes,etc and help in identify function impairment, social and economic burden

Other names: socioeconomic class, pediatric quality of life inventory, The Strengths and Difficulties Questionnaire (SDQ),The Mood and Feelings Questionnaire (MFQ),

Primary outcomes

  1. measure intellectual equations for children with epilepsy and ADHD

    Time frame: baseline

    WISC-III provided scores for Verbal IQ (VIQ), Performance IQ (PIQ), and Full-Scale IQ (FSIQ).

    The child's verbal IQ score was derived from scores on six of the subtests: information, digit span, vocabulary, arithmetic, comprehension, and similarities.

    The child's performance IQ was derived from scores on the remaining seven subtests: picture completion, picture arrangement, block design, object assembly, coding, mazes, and symbol search.

    The overall intelligence quotient, called the full scale IQ, as well as a verbal IQ and a performance IQ. The three IQ scores are standardized in such a way that a score of 100 is considered average and serves as a benchmark for higher and lower scores.

  2. measure socioeconomic class for families and children with comorbid epilepsy and ADHD

    Time frame: baseline

    It will be measure by Socioeconomic class scale which consist of It contain four main variables 1-the educational level of the father and mother 2-the occupation of the father and mother 3-total family income 4-life style of the family. The total score of the scale equal the sum of scores in each level, the scores 36-42 mean the high socioeconomic class, the scores 21-26 mean the low socioeconomic class, and scores between them mean the middle class.

  3. measure mood and feeling changes in children with comorbid epilepsy and ADHD.

    Time frame: baseline

    It will be measure by Mood and Feelings Questionnaire (MFQ) arent Report is a 13-item measure assessing recent depressive and describe feelings and mood,more than 26 is consider for evaluation of depression

  4. measure quality of life for children with comorbid epilepsy and ADHD

    Time frame: baseline

    It is composed of 23 items that assessment function in the following four areas: physical (eight items), emotional (five items), social (five items), and school (five items). Patients report their function using a 5-point Likert scale ranging from 0 to 4. These responses are reverse scored and linearly transformed to a 0 to 100 scale, with a higher score indicating a higher QOL.

    The Psychosocial Health Summary score is a computed mean of the emotional, social, and school functioning subscales of the PedsQL. The physical functioning scale is the same as the Physical Summary score. In addition, the computed mean of the Emotional, Social, School functioning, and Physical scales are used to generate a Total Summary score. PedsQL scales are composed of parallel child self-report and parent-proxy report formats.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jan 16, 2019
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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