NCT05874765

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

May 16, 2023

Last Update Submit

May 16, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Diagnostic and Statistical Manual of mental disorder- fifth edition ( DSM5) , will be used to diagnose and classify the Tics among all included patients

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

* -Age between 3 and 18 years * All patients suffering from Tics and fulfill diagnostic criteria according to DSM V

You may qualify if:

  • Age between 3 and 18 years
  • All patients suffering from Tics and fulfill diagnostic criteria according to DSM V

You may not qualify if:

  • \- Patients with age below 3 years and after 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 2768151BACKGROUND
  • 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.

    PMID: 24826496BACKGROUND

MeSH Terms

Conditions

Tic Disorders

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Esraa A Mohammed, resident

CONTACT

Montaser M Mohammed, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident-pediatric department-sohag hospital university

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 25, 2023

Study Start

June 1, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations