Impact of Relationship of Epilepsy and Attention Deficit Hyperactive Disorder

April 13, 2020 updated by: Gellan Karamalllah Ramadan Ahmed, Assiut University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Assiut University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group1
ADHD with normal EEG
Diagnostic test: electroencephalography
diagnosis epileptic discharge
Other Names:
  • EEG
Diagnostic test: psychometric scales to diagnosis psychiatric disorders
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)
Other: psychometric scales for assesment socioeconomic and behaviour problems
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),
group 2
ADHD with abnormal EEG
Diagnostic test: electroencephalography
diagnosis epileptic discharge
Other Names:
  • EEG
Diagnostic test: psychometric scales to diagnosis psychiatric disorders
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)
Other: psychometric scales for assesment socioeconomic and behaviour problems
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),
group 3
Epilepsy
Diagnostic test: electroencephalography
diagnosis epileptic discharge
Other Names:
  • EEG
Diagnostic test: psychometric scales to diagnosis psychiatric disorders
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)
Other: psychometric scales for assesment socioeconomic and behaviour problems
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),
group 4
Healthy control group
Diagnostic test: electroencephalography
diagnosis epileptic discharge
Other Names:
  • EEG
Diagnostic test: psychometric scales to diagnosis psychiatric disorders
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)
Other: psychometric scales for assesment socioeconomic and behaviour problems
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),
group 5
ADHD and epilepsy
Diagnostic test: electroencephalography
diagnosis epileptic discharge
Other Names:
  • EEG
Diagnostic test: psychometric scales to diagnosis psychiatric disorders
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)
Other: psychometric scales for assesment socioeconomic and behaviour problems
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),

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline
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
baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Alaa El-Din Darweesh, PhD, Assiut University
  • Study Chair: HossamEddin Ahmad, PhD, Assiut University
  • Study Chair: Patrick Bolton, PhD, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2019

Primary Completion (ACTUAL)

December 30, 2019

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

January 12, 2019

First Posted (ACTUAL)

January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Impact of ADHD and epilepsy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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