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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05874765
Other study ID # Soh-Med-23-04-19MS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2023
Est. completion date June 2024

Study information

Verified date May 2023
Source Sohag University
Contact Esraa A Mohammed, resident
Phone 01099711828
Email esraaahmed@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria: - -Age between 3 and 18 years - All patients suffering from Tics and fulfill diagnostic criteria according to DSM V Exclusion Criteria: - - Patients with age below 3 years and after 18 years old

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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

Locations

Country Name City State
Egypt Sohag university Hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Barker 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03705988 - A Study of Cranial Electrotherapy Stimulation as an Add-on Treatment for Tic Disorders (SCATT) N/A
Completed NCT04578912 - Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics N/A
Recruiting NCT05696769 - Tourette Discrimination (TD) Stigma Scale
Completed NCT04878302 - Improving Symptom Trajectories of Tic Disorders and Co-occurring Diagnoses: The Role of Integrative Intensive Intervention N/A