<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03817710</url>
  </required_header>
  <id_info>
    <org_study_id>POTIADHD</org_study_id>
    <nct_id>NCT03817710</nct_id>
  </id_info>
  <brief_title>Tics in Childern With Acute Deficit Hyper Activity Syndrom</brief_title>
  <official_title>Prevalence of Tics in Childern With Acute Deficit Hyper Activity Syndrom</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tics have been defined as sudden, rapid, recurrent, non-rhythmic, stereotyped, involuntary&#xD;
      movements or vocalizations. Motor tic can be either simple or complex, depending on whether&#xD;
      one or several muscle groups are simultaneously or concurrently affected. Motor tics commonly&#xD;
      include behaviours such as eye blinking, lip-licking, or mouth opening. It can also involve&#xD;
      more complex movements like facial grimacing ,head movements , shoulder shrugging or&#xD;
      combinations of these.Vocal or phonic tics are involuntary sounds that include throat&#xD;
      clearing, coughing, barking, sniffing, unnecessary belching or more complex vocalizations&#xD;
      such as repeating parts of words or phrases.&#xD;
&#xD;
      Gilles de la Tourette's syndrome is complex neurodevelopmental disorder characterized by&#xD;
      combination of motor and vocal tics. Motor tics often precede the onset of phonic tics by&#xD;
      many years. The phonic tics may commence from about the age of 3 years. Severe Tourette's&#xD;
      Syndrome may manifest as forceful bouts of self-harming motor tics, including hitting or&#xD;
      biting, as well as socially unacceptable utterances (coprolalia) and gestures [3].&#xD;
&#xD;
      The Tourette's Syndrome Study Group definition from 1993 requires the concurrent presence of&#xD;
      motor and vocal tics occurring almost daily for at least one year, [4]. The Diagnostic and&#xD;
      Statistical Manual of Mental Disorders 5th Edition requires both multiple motor and one or&#xD;
      more vocal tics have been present at some time during the illness, although not necessarily&#xD;
      concurrently for the diagnosis of Tourette's Syndrome . It also describes Tics Disorder and&#xD;
      Tourette's Syndrome as waxing and waning in frequency and symptoms must have lasted for more&#xD;
      than one year since the first onset.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The average age of developing Tourette's Syndrome is 7 years, with a range from three to&#xD;
      eight years. Most patients with childhood tics disorder show remarkable symptoms improvement&#xD;
      by the age of 19 years. Adult-onset cases of Tourette's Syndrome are usually the most severe&#xD;
      forms of presentation...&#xD;
&#xD;
      Motor or phonic tics often begin with the patient experiencing some psycho-sensory phenomena&#xD;
      known as the &quot;premonitory urge&quot; which may be localized to an area of the tics or a&#xD;
      generalised inner tension. Most individuals with Tics/ Tourette's Syndrome also experience&#xD;
      feelings of momentary relief after the tic has occurred. TICS Disorder are typically&#xD;
      exacerbated by stressful life-events associated with high levels of emotional excitements and&#xD;
      fatigue, and can include normally routine activities such as the start of school, birthdays,&#xD;
      arrival of a new sibling, changes in the social or physical environment like moving house or&#xD;
      going on holidays. The symptoms of childhood Tics Disorder / Tourette's Syndrome are usually&#xD;
      mild and they are almost invariably co-morbid with other mental health and behavioural&#xD;
      problems including ADHD, Obsessive-compulsive disorder (OCD), learning disabilities (LD) and&#xD;
      mood disorders. Tics/ Tourette's Syndrome can significantly impair the patient's self-esteem,&#xD;
      peer and or family relationships[3]. Although tics often improve after adolescence, recent&#xD;
      studies suggest that comorbid OCD and ADHD often persist.&#xD;
&#xD;
      Other common comorbidities in children with Tics/ Tourette's Syndrome include anxiety&#xD;
      disorders, depression, autistic spectrum disorder (ASD), conduct disorder (CD), oppositional&#xD;
      defiant disorder (ODD), self-injurious behaviours, sleep disorders, rage attacks and&#xD;
      personality disorder.&#xD;
&#xD;
      ADHD :&#xD;
&#xD;
      Attention deficit hyperactivity disorder (ADHD) is the commonest neurobehavioural disorder in&#xD;
      children and adolescents, with prevalence ranging between 5% and 12% in the developed&#xD;
      countries[2]. Up to 80% of ADHD patients have one or more co-morbid conditions which include&#xD;
      Tics disorders (TD). There is a complex interplay between Tics Disorder and ADHD in children&#xD;
      and young people. TDs are common comorbidities in paediatric ADHD patients with or without&#xD;
      treatment with pharmacotherapy. ADHD and other co-morbid disorders like Tics/ Tourette's&#xD;
      syndrome (TS), especially if left untreated, can have lasting impairing effects on several&#xD;
      aspects of daily functioning. Tics naturally wax and wane in clinical severity and are&#xD;
      exacerbated by stress, including consequences of untreated ADHD. There has been conflicting&#xD;
      evidence of the role of psychostimulants in either precipitating or exacerbating TDs in ADHD&#xD;
      patients. Some evidence also suggests that tics may improve with ADHD treatment Tics&#xD;
      naturally wax and wane in clinical severity and are exacerbated by stress, including&#xD;
      consequences of untreated ADHD. There has been conflicting evidence of the role of&#xD;
      psychostimulants in either precipitating or exacerbating TDs in ADHD patients. Some evidence&#xD;
      also suggests that tics may improve with ADHD treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2019</start_date>
  <completion_date type="Anticipated">November 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of Tics Disorder in Children With ADHD</measure>
    <time_frame>one year</time_frame>
    <description>Prevalence of Tics Disorder in Children With ADHD</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Behavior Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All cases will subjected for full clinical history including different manifestation of&#xD;
        tics Data were collected from (Children Hospital ) Assiut University outpatient clinics&#xD;
        with the purpose to study tics in children with ADHD.( ADHD Score)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infants with ADHD aged between 2 and 18 years (old and new).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants below 2 or above 18 .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Biederman J, Faraone SV. Attention-deficit hyperactivity disorder. Lancet. 2005 Jul 16-22;366(9481):237-48. doi: 10.1016/S0140-6736(05)66915-2. Erratum In: Lancet. 2006 Jan 21;367(9506):210.</citation>
    <PMID>16023516</PMID>
  </reference>
  <reference>
    <citation>Faraone SV, Sergeant J, Gillberg C, Biederman J. The worldwide prevalence of ADHD: is it an American condition? World Psychiatry. 2003 Jun;2(2):104-13.</citation>
    <PMID>16946911</PMID>
  </reference>
  <results_reference>
    <citation>Anckarsater H, Lundstrom S, Kollberg L, Kerekes N, Palm C, Carlstrom E, Langstrom N, Magnusson PK, Halldner L, Bolte S, Gillberg C, Gumpert C, Rastam M, Lichtenstein P. The Child and Adolescent Twin Study in Sweden (CATSS). Twin Res Hum Genet. 2011 Dec;14(6):495-508. doi: 10.1375/twin.14.6.495.</citation>
    <PMID>22506305</PMID>
  </results_reference>
  <results_reference>
    <citation>Beau-Lejdstrom R, Douglas I, Evans SJ, Smeeth L. Latest trends in ADHD drug prescribing patterns in children in the UK: prevalence, incidence and persistence. BMJ Open. 2016 Jun 13;6(6):e010508. doi: 10.1136/bmjopen-2015-010508.</citation>
    <PMID>27297009</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Atef Hassobba</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <keyword>tics disorder in childern with acute deficit hyper activity syndrom</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03817710
org study id: POTIADHD
nct id: NCT03817710
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Tics have been defined as sudden, rapid, recurrent, non-rhythmic, stereotyped, involuntary
      movements or vocalizations. Motor tic can be either simple or complex, depending on whether
      one or several muscle groups are simultaneously or concurrently affected. Motor tics commonly
      include behaviours such as eye blinking, lip-licking, or mouth opening. It can also involve
      more complex movements like facial grimacing ,head movements , shoulder shrugging or
      combinations of these.Vocal or phonic tics are involuntary sounds that include throat
      clearing, coughing, barking, sniffing, unnecessary belching or more complex vocalizations
      such as repeating parts of words or phrases.

      Gilles de la Tourette's syndrome is complex neurodevelopmental disorder characterized by
      combination of motor and vocal tics. Motor tics often precede the onset of phonic tics by
      many years. The phonic tics may commence from about the age of 3 years. Severe Tourette's
      Syndrome may manifest as forceful bouts of self-harming motor tics, including hitting or
      biting, as well as socially unacceptable utterances (coprolalia) and gestures [3].

      The Tourette's Syndrome Study Group definition from 1993 requires the concurrent presence of
      motor and vocal tics occurring almost daily for at least one year, [4]. The Diagnostic and
      Statistical Manual of Mental Disorders 5th Edition requires both multiple motor and one or
      more vocal tics have been present at some time during the illness, although not necessarily
      concurrently for the diagnosis of Tourette's Syndrome . It also describes Tics Disorder and
      Tourette's Syndrome as waxing and waning in frequency and symptoms must have lasted for more
      than one year since the first onset.
The average age of developing Tourette's Syndrome is 7 years, with a range from three to
      eight years. Most patients with childhood tics disorder show remarkable symptoms improvement
      by the age of 19 years. Adult-onset cases of Tourette's Syndrome are usually the most severe
      forms of presentation...

      Motor or phonic tics often begin with the patient experiencing some psycho-sensory phenomena
      known as the "premonitory urge" which may be localized to an area of the tics or a
      generalised inner tension. Most individuals with Tics/ Tourette's Syndrome also experience
      feelings of momentary relief after the tic has occurred. TICS Disorder are typically
      exacerbated by stressful life-events associated with high levels of emotional excitements and
      fatigue, and can include normally routine activities such as the start of school, birthdays,
      arrival of a new sibling, changes in the social or physical environment like moving house or
      going on holidays. The symptoms of childhood Tics Disorder / Tourette's Syndrome are usually
      mild and they are almost invariably co-morbid with other mental health and behavioural
      problems including ADHD, Obsessive-compulsive disorder (OCD), learning disabilities (LD) and
      mood disorders. Tics/ Tourette's Syndrome can significantly impair the patient's self-esteem,
      peer and or family relationships[3]. Although tics often improve after adolescence, recent
      studies suggest that comorbid OCD and ADHD often persist.

      Other common comorbidities in children with Tics/ Tourette's Syndrome include anxiety
      disorders, depression, autistic spectrum disorder (ASD), conduct disorder (CD), oppositional
      defiant disorder (ODD), self-injurious behaviours, sleep disorders, rage attacks and
      personality disorder.

      ADHD :

      Attention deficit hyperactivity disorder (ADHD) is the commonest neurobehavioural disorder in
      children and adolescents, with prevalence ranging between 5% and 12% in the developed
      countries[2]. Up to 80% of ADHD patients have one or more co-morbid conditions which include
      Tics disorders (TD). There is a complex interplay between Tics Disorder and ADHD in children
      and young people. TDs are common comorbidities in paediatric ADHD patients with or without
      treatment with pharmacotherapy. ADHD and other co-morbid disorders like Tics/ Tourette's
      syndrome (TS), especially if left untreated, can have lasting impairing effects on several
      aspects of daily functioning. Tics naturally wax and wane in clinical severity and are
      exacerbated by stress, including consequences of untreated ADHD. There has been conflicting
      evidence of the role of psychostimulants in either precipitating or exacerbating TDs in ADHD
      patients. Some evidence also suggests that tics may improve with ADHD treatment Tics
      naturally wax and wane in clinical severity and are exacerbated by stress, including
      consequences of untreated ADHD. There has been conflicting evidence of the role of
      psychostimulants in either precipitating or exacerbating TDs in ADHD patients. Some evidence
      also suggests that tics may improve with ADHD treatment
observational model: Case-Only
time perspective: Retrospective
measure: Prevalence of Tics Disorder in Children With ADHD
time frame: one year
description: Prevalence of Tics Disorder in Children With ADHD
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Biederman J, Faraone SV. Attention-deficit hyperactivity disorder. Lancet. 2005 Jul 16-22;366(9481):237-48. doi: 10.1016/S0140-6736(05)66915-2. Erratum In: Lancet. 2006 Jan 21;367(9506):210.
PMID: 16023516
citation: Faraone SV, Sergeant J, Gillberg C, Biederman J. The worldwide prevalence of ADHD: is it an American condition? World Psychiatry. 2003 Jun;2(2):104-13.
PMID: 16946911
citation: Anckarsater H, Lundstrom S, Kollberg L, Kerekes N, Palm C, Carlstrom E, Langstrom N, Magnusson PK, Halldner L, Bolte S, Gillberg C, Gumpert C, Rastam M, Lichtenstein P. The Child and Adolescent Twin Study in Sweden (CATSS). Twin Res Hum Genet. 2011 Dec;14(6):495-508. doi: 10.1375/twin.14.6.495.
PMID: 22506305
citation: Beau-Lejdstrom R, Douglas I, Evans SJ, Smeeth L. Latest trends in ADHD drug prescribing patterns in children in the UK: prevalence, incidence and persistence. BMJ Open. 2016 Jun 13;6(6):e010508. doi: 10.1136/bmjopen-2015-010508.
PMID: 27297009
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Atef Hassobba
investigator title: principle investigator
mesh term: Hyperkinesis
mesh term: Mental Disorders
sharing ipd: Undecided