Behavior DisordersNCT03817710
Tics in Childern With Acute Deficit Hyper Activity Syndrom
An observational study of Behavior Disorders, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Disorders
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All cases will subjected for full clinical history including different manifestation of tics Data were collected from (Children Hospital ) Assiut University outpatient clinics with the purpose to study tics in children with ADHD.( ADHD Score)
Who may be able to join
- infants with ADHD aged between 2 and 18 years (old and new).
Who cannot join
- Infants below 2 or above 18 .
About this study
Official title: Prevalence of Tics in Childern With Acute Deficit Hyper Activity Syndrom
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.
Read the detailed description
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
- Conditions
- Behavior Disorders
- Keywords
- tics disorder in childern with acute deficit hyper activity syndrom
- Medical subject headings
- Mental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Tics Disorder in Children With ADHD
Prevalence of Tics Disorder in Children With ADHD
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Behavior DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Atef Hassobba, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817710
- Sponsor's protocol ID
- POTIADHD
- Status last verified
- Jan 2019
- First submitted
- 24 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16023516Faraone 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.
PubMed 16946911Anckarsater 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.
PubMed 22506305Beau-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.
PubMed 27297009
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Tics in Childern With Acute Deficit Hyper Activity Syndrom
- ClinicalTrials.gov ID
- NCT03817710
- Acronym / sponsor ID
- POTIADHD
- Conditions
- Behavior Disorders
- Keywords
- tics disorder in childern with acute deficit hyper activity syndrom
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All cases will subjected for full clinical history including different manifestation of tics Data were collected from (Children Hospital ) Assiut University outpatient clinics with the purpose to study tics in children with ADHD.( ADHD Score)
Key inclusion criteria (1 listed)
- infants with ADHD aged between 2 and 18 years (old and new).
Key exclusion criteria (1 listed)
- Infants below 2 or above 18 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Tics Disorder in Children With ADHD
Time frame: one year
Prevalence of Tics Disorder in Children With ADHD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Background: PubMed 16023516Biederman J, Faraone SV. Attention-deficit hyperactivity disorder. Lancet. 2005 Jul 16-22;366(9481):237-48. doi: 10.1016/S0140-6736(05)66915-2.
- Background: PubMed 16946911Faraone 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.
- Results publication: PubMed 22506305Anckarsater 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.
- Results publication: PubMed 27297009Beau-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavior Disorders, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Tics Disorder in Children With ADHD (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03817710, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.