The purpose of the study is to identify genes and genetic mechanisms that contribute to TD, chronic tics, and related clinical disorders including OCD and ADHD in individuals with these clinical phenotypes and their relatives.
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence of TD or other tic disorders (including chronic motor or vocal tic
disorder, transient tic disorder, and tic disorder not otherwise specified).
Secondary outcome
Symptoms of OCD (including subclinical OCD and Obsessive-Compulsive personality
disorder); symptoms of ADHD and trichotillomania.
Background summary
Tourette*s Disorder (TD) is a developmental neuropsychiatric syndrome
characterized by persistent vocal and motor tics. While initially considered
rare, the prevalence is now estimated to be 0.3-1%. Both as a result of
potentially disabling symptoms and high rates of psychiatric co-morbidity,
particularly with obsessive-compulsive disorder (OCD) and
attention-deficit/hyperactivity disorder (ADHD), TD represents a significant
public health concern. This protocol is part of an international collaborative
group, entitled *Tourette International Collaborative Genetics (TIC
Genetics)*. The DNA, cell lines, and clinical information will be stored at
Rutgers University as part of the National Institutes of Mental Health (NIMH)
Center for Collaborative Genetic Studies on Mental Disorders as an
international resource.
Study objective
The purpose of the study is to identify genes and genetic mechanisms that
contribute to TD, chronic tics, and related clinical disorders including OCD
and ADHD in individuals with these clinical phenotypes and their relatives.
Study design
This is an international cross-sectional genetic biobanking multicenter study
in which seven US sites, fourteen European sites (including three recruiting
sites from the Netherlands: UMCG, Yulius, de Bascule), and six South-Korean
sites will perform a diagnostic assessment, followed by a single blood draw,
aimed in 6300 individuals over a study period from 2011 to 2024, all being
either parent-child trio*s or affected or unaffected members of pedigrees with
three or more affected members with TD or chronic tics. European sites together
will recruit at least 25 multiply affected extended families plus parent-child
trio*s with a maximum of 2100 subjects over the study period 2011-2024.
Study burden and risks
The burden will be completion of a questionnaire (60 minutes), a single
clinical evaluation (60 minutes), and a blood draw (15 minutes) through
venipuncture. Risks will be negligible. Subjects will not receive any direct
benefits from participation in the research. This research protocol includes
the participation of minors. Tic disorders have a childhood onset, with tics
usually starting around the age of 6.
Hanzeplein 1, XA-10
Groningen 9713 GZ
NL
Hanzeplein 1, XA-10
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Either parent-child trios (i.e. affected person with Tourette's disorder plus
his/her biological parents) or extended pedigrees, with a primary proband with
Tourette's disorder and at least two relatives (up to the fourth degree) who
are affected with Tourette's Disorder or chronic motor tic disorder.
Exclusion criteria
No informed consent or resistance of minors against blood sampling
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37812.042.11 |