Tic Disorder, ChildhoodNCT05874765
A Study of Prevalence and Clinical Characteristics of Tic Disorders in Children at Sohag University Hospital
An observational study of Tic Disorder, Childhood, run by Sohag University at 1 site in Egypt.
Trial summary
Tics are brief, sudden, repetitive movements and/or sounds that increase with stress, anxiety, transitions, or excitement. Tics occur most commonly in children and adolescents, with boys more frequently affected than girls The American Academy of Child and Adolescent Psychiatry states that tics affect up to 10 percent… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Tic Disorder, Childhood
- What is being tested?
- Diagnostic and Statistical Manual of mental disorder- fifth edition ( DSM5)
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2023to Jun 2024
- 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 3 to 18 years
- All sexes
- Child, Adult
Study population: * -Age between 3 and 18 years * All patients suffering from Tics and fulfill diagnostic criteria according to DSM V
Who may be able to join
- -Age between 3 and 18 years
- All patients suffering from Tics and fulfill diagnostic criteria according to DSM V
Who cannot join
- - Patients with age below 3 years and after 18 years old
Trial locations and contacts
1 site in 1 country.
Montaser M Mohammed, professor contact
About this study
Tics are brief, sudden, repetitive movements and/or sounds that increase with stress, anxiety, transitions, or excitement.
Tics occur most commonly in children and adolescents, with boys more frequently affected than girls The American Academy of Child and Adolescent Psychiatry states that tics affect up to 10 percent of children during their early school years. .
Read more
The exact pathophysiologic mechanisms are unknown, but the disorders are likely to be due to disturbances of the cortico striatal- thalamo -circuitry. Risk factors for tic disorders include. Genetics: Tics tend to run in families, so there may be a genetic basis to these disorders. Sex: Men are more likely to be affected by tic disorders than women.
They are divided into motor tics (e.g., blinking, shrugging shoulders, grimacing, or jerking) and vocal tics (e.g., throat clearing, sniffing, grunting) .
Patients describe an inner urge or a local premonitory sensation, which is then relieved by performing the tic. The tic can be voluntarily suppressed for short periods of time. Tics increase with stress, anxiety, transitions, and excitement, and decrease with distraction.
The American Academy of Child and Adolescent Psychiatry states that tics affect up to 10 percent of children during their early school years .The most notable tic disorder is Tourette syndrome, in which both physical and verbal tics occur in the same individual, often at the same time. Transient tic disorder also involves both types of tics, but they often occur individually .
Tic disorders are classified into 3 categories : Transient tic disorders involve motor or vocal tics that last for more than 4 weeks but less than a year. Chronic tic disorders involve either motor tics or vocal tics (but not both) that last for more than a year. Tourette Syndrome, in which both physical and verbal tics occur in the same individual Conditions associated with tic disorders, especially in children with TS, include: anxiety, ADHD, depression ,autism ,spectrum disorder learning difficulties ,OCD speech and language difficulties, sleep difficulties other complications associated with tic disorders are related to the effect of the tics on self-esteem and self-image . Some research! has found that children with TS or any chronic tic disorder experience a lower quality of life and lower self-esteem than those without one of these conditions
- Conditions
- Tic Disorder, Childhood
- Being tested
- Diagnostic and Statistical Manual of mental disorder- fifth edition ( DSM5)
- Medical subject headings
- Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic and Statistical Manual of mental disorder- fifth edition ( DSM5)Diagnostic test
Diagnostic and Statistical Manual of mental disorder- fifth edition ( DSM5) , will be used to diagnose and classify the Tics among all included patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Tics severity will be by The Yale Global Tic Severity Scale ( Y G T S S-R)
A clinician-rated instrument considerd as the gold standard for assessing tics in patients with Trourettes Syndrome and other tic disorders
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study startJun 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tic Disorder, ChildhoodStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ahmed Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874765
- Sponsor's protocol ID
- Soh-Med-23-04-19MS
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.
PubMed 2768151Barker A, Musso MW, Jones GN, Roid G, Gouvier D. Unreliable block span reveals simulated intellectual disability on the stanford-binet intelligence scales-fifth edition. Appl Neuropsychol Adult. 2014;21(1):51-9. doi: 10.1080/09084282.2012.726670. Epub 2013 Jun 21.
PubMed 24826496
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Prevalence and Clinical Characteristics of Tic Disorders in Children at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05874765
- Acronym / sponsor ID
- Soh-Med-23-04-19MS
- Conditions
- Tic Disorder, Childhood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 25 May 2023 (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 are brief, sudden, repetitive movements and/or sounds that increase with stress, anxiety, transitions, or excitement.
Tics occur most commonly in children and adolescents, with boys more frequently affected than girls The American Academy of Child and Adolescent Psychiatry states that tics affect up to 10 percent of children during their early school years. .
The exact pathophysiologic mechanisms are unknown, but the disorders are likely to be due to disturbances of the cortico striatal- thalamo -circuitry. Risk factors for tic disorders include. Genetics: Tics tend to run in families, so there may be a genetic basis to these disorders. Sex: Men are more likely to be affected by tic disorders than women.
They are divided into motor tics (e.g., blinking, shrugging shoulders, grimacing, or jerking) and vocal tics (e.g., throat clearing, sniffing, grunting) .
Patients describe an inner urge or a local premonitory sensation, which is then relieved by performing the tic. The tic can be voluntarily suppressed for short periods of time. Tics increase with stress, anxiety, transitions, and excitement, and decrease with distraction.
The American Academy of Child and Adolescent Psychiatry states that tics affect up to 10 percent of children during their early school years .The most notable tic disorder is Tourette syndrome, in which both physical and verbal tics occur in the same individual, often at the same time. Transient tic disorder also involves both types of tics, but they often occur individually .
Tic disorders are classified into 3 categories : Transient tic disorders involve motor or vocal tics that last for more than 4 weeks but less than a year. Chronic tic disorders involve either motor tics or vocal tics (but not both) that last for more than a year. Tourette Syndrome, in which both physical and verbal tics occur in the same individual Conditions associated with tic disorders, especially in children with TS, include: anxiety, ADHD, depression ,autism ,spectrum disorder learning difficulties ,OCD speech and language difficulties, sleep difficulties other complications associated with tic disorders are related to the effect of the tics on self-esteem and self-image . Some research! has found that children with TS or any chronic tic disorder experience a lower quality of life and lower self-esteem than those without one of these conditions
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- * -Age between 3 and 18 years * All patients suffering from Tics and fulfill diagnostic criteria according to DSM V
Key inclusion criteria (2 listed)
- -Age between 3 and 18 years
- All patients suffering from Tics and fulfill diagnostic criteria according to DSM V
Key exclusion criteria (1 listed)
- - Patients with age below 3 years and after 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic and Statistical Manual of mental disorder- fifth edition ( DSM5)Diagnostic and Statistical Manual of mental disorder- fifth edition ( DSM5) , will be used to diagnose and classify the Tics among all included patients | Diagnostic test | – |
Primary outcome
Assessment of Tics severity will be by The Yale Global Tic Severity Scale ( Y G T S S-R)
Time frame: 12 months
A clinician-rated instrument considerd as the gold standard for assessing tics in patients with Trourettes Syndrome and other tic disorders
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Background: PubMed 2768151Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.
- Background: PubMed 24826496Barker A, Musso MW, Jones GN, Roid G, Gouvier D. Unreliable block span reveals simulated intellectual disability on the stanford-binet intelligence scales-fifth edition. Appl Neuropsychol Adult. 2014;21(1):51-9. doi: 10.1080/09084282.2012.726670. Epub 2013 Jun 21.
- 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.
Montaser M Mohammed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tic Disorder, Childhood, run by Sohag University at 1 site in Egypt.
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 2 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 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Esraa A Mohammed, resident (01099711828, esraaahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Tics severity will be by The Yale Global Tic Severity Scale ( Y G T S S-R) (time frame: 12 months). 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 NCT05874765, which also lists 2 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 May 2023.