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Impact of Relationship of Epilepsy and Attention Deficit Hyperactive Disorder

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ClinicalTrials.gov Identifier: NCT03806946
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Gellan Karamalllah Ramadan Ahmed, Assiut University

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.

Condition or disease Intervention/treatment
Attention-Deficit Hyperactivity Disorder Epilepsy Diagnostic Test: electroencephalography Diagnostic Test: psychometric scales to diagnosis psychiatric disorders Other: psychometric scales for assesment socioeconomic and behaviour problems

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


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Impact of Relationship of Epilepsy and Attention Deficit Hyperactive Disorder
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
group1
ADHD without epilepsy.
Diagnostic Test: electroencephalography
diagnosis epileptic discharge
Other Name: EEG

Diagnostic Test: psychometric scales to diagnosis psychiatric disorders
to diagnosis intellectual disability, attention deficit hyperactivity disorder ,epilepsy,autism and other mental illness.
Other Name: 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 Name: socioeconomic class, Zarit Carer Burden Interview,pediatric quality of life inventory, ,The Strengths and Difficulties Questionnaire (SDQ),The Mood and Feelings Questionnaire (MFQ),

group 2
ADHD comorbid with epilepsy.
Diagnostic Test: electroencephalography
diagnosis epileptic discharge
Other Name: EEG

Diagnostic Test: psychometric scales to diagnosis psychiatric disorders
to diagnosis intellectual disability, attention deficit hyperactivity disorder ,epilepsy,autism and other mental illness.
Other Name: 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 Name: socioeconomic class, Zarit Carer Burden Interview,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 Name: EEG

Diagnostic Test: psychometric scales to diagnosis psychiatric disorders
to diagnosis intellectual disability, attention deficit hyperactivity disorder ,epilepsy,autism and other mental illness.
Other Name: 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 Name: socioeconomic class, Zarit Carer Burden Interview,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 Name: EEG

Diagnostic Test: psychometric scales to diagnosis psychiatric disorders
to diagnosis intellectual disability, attention deficit hyperactivity disorder ,epilepsy,autism and other mental illness.
Other Name: 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 Name: socioeconomic class, Zarit Carer Burden Interview,pediatric quality of life inventory, ,The Strengths and Difficulties Questionnaire (SDQ),The Mood and Feelings Questionnaire (MFQ),




Primary Outcome Measures :
  1. measure intellectual equations for children with epilepsy and ADHD [ Time Frame: baseline ]
    All participants will be evaluated by The WISC-III is a collection of 13 distinct subtest divided into two scales - a Verbal Scale and a Performance Scale. The six Verbal Scale tests use language-based items, whereas the seven Performance Scales use visual-motor items that are less dependent on language.

  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.

  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

  4. measure quality of life for children with comorbid epilepsy and ADHD [ Time Frame: baseline ]
    It will be measure by Paediatric Quality of Life Inventory which is consists of a 15-item core measure pediatric quality of life and eight supplemental modules assessing specific symptom , treatment domains,functional problems (physical, emotional and social) that are most troublesome to children.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (5y-12y)
Criteria

Inclusion Criteria:

  1. Age between 5 and 12.
  2. Diagnosis of ADHD and epilepsy were verified and confirmed either on a clinical basis or by using reliable psychometric tests.
  3. Willing of the parents or the caregivers to participate in the study

Exclusion Criteria:

  • Subjects refuse to share in research
  • presence of substance abuse or intellectual disability.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806946


Contacts
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Contact: Gellan Ahmed, master 01020778930 ext 002 gillankaram@aun.edu.eg
Contact: Alaa El-Din Darweesh, PhD 01005279326 assiutbird25@aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
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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 of Results:
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Responsible Party: Gellan Karamalllah Ramadan Ahmed, Assistent lecture, Assiut University
ClinicalTrials.gov Identifier: NCT03806946     History of Changes
Other Study ID Numbers: Impact of ADHD and epilepsy
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Epilepsy
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms