NCT03817710

Brief 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. 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.

Trial Health

35
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 Oct 2019

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

January 24, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

January 24, 2019

Last Update Submit

January 24, 2019

Conditions

Keywords

tics disorder in childern with acute deficit hyper activity syndrom

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Tics Disorder in Children With ADHD

    Prevalence of Tics Disorder in Children With ADHD

    one year

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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)

You may qualify if:

  • infants with ADHD aged between 2 and 18 years (old and new).

You may not qualify if:

  • Infants below 2 or above 18 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 16023516BACKGROUND
  • 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: 16946911BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 25, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

January 25, 2019

Record last verified: 2019-01