Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03817710
Other study ID # POTIADHD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date November 1, 2020

Study information

Verified date January 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

The average age of developing Tourette's Syndrome is 7 years, with a range from three to eight years. Most patients with childhood tics disorder show remarkable symptoms improvement by the age of 19 years. Adult-onset cases of Tourette's Syndrome are usually the most severe forms of presentation...

Motor or phonic tics often begin with the patient experiencing some psycho-sensory phenomena known as the "premonitory urge" which may be localized to an area of the tics or a generalised inner tension. Most individuals with Tics/ Tourette's Syndrome also experience feelings of momentary relief after the tic has occurred. TICS Disorder are typically exacerbated by stressful life-events associated with high levels of emotional excitements and fatigue, and can include normally routine activities such as the start of school, birthdays, arrival of a new sibling, changes in the social or physical environment like moving house or going on holidays. The symptoms of childhood Tics Disorder / Tourette's Syndrome are usually mild and they are almost invariably co-morbid with other mental health and behavioural problems including ADHD, Obsessive-compulsive disorder (OCD), learning disabilities (LD) and mood disorders. Tics/ Tourette's Syndrome can significantly impair the patient's self-esteem, peer and or family relationships[3]. Although tics often improve after adolescence, recent studies suggest that comorbid OCD and ADHD often persist.

Other common comorbidities in children with Tics/ Tourette's Syndrome include anxiety disorders, depression, autistic spectrum disorder (ASD), conduct disorder (CD), oppositional defiant disorder (ODD), self-injurious behaviours, sleep disorders, rage attacks and personality disorder.

ADHD :

Attention deficit hyperactivity disorder (ADHD) is the commonest neurobehavioural disorder in children and adolescents, with prevalence ranging between 5% and 12% in the developed countries[2]. Up to 80% of ADHD patients have one or more co-morbid conditions which include Tics disorders (TD). There is a complex interplay between Tics Disorder and ADHD in children and young people. TDs are common comorbidities in paediatric ADHD patients with or without treatment with pharmacotherapy. ADHD and other co-morbid disorders like Tics/ Tourette's syndrome (TS), especially if left untreated, can have lasting impairing effects on several aspects of daily functioning. Tics naturally wax and wane in clinical severity and are exacerbated by stress, including consequences of untreated ADHD. There has been conflicting evidence of the role of psychostimulants in either precipitating or exacerbating TDs in ADHD patients. Some evidence also suggests that tics may improve with ADHD treatment Tics naturally wax and wane in clinical severity and are exacerbated by stress, including consequences of untreated ADHD. There has been conflicting evidence of the role of psychostimulants in either precipitating or exacerbating TDs in ADHD patients. Some evidence also suggests that tics may improve with ADHD treatment


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date November 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Infants below 2 or above 18 .

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Anckarsäter H, Lundström S, Kollberg L, Kerekes N, Palm C, Carlström E, Långström N, Magnusson PK, Halldner L, Bölte S, Gillberg C, Gumpert C, Råstam M, Lichtenstein P. The Child and Adolescent Twin Study in Sweden (CATSS). Twin Res Hum Genet. 2011 Dec;14 — View Citation

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. — View Citation

Biederman J, Faraone SV. Attention-deficit hyperactivity disorder. Lancet. 2005 Jul 16-22;366(9481):237-48. Review. Erratum in: Lancet. 2006 Jan 21;367(9506):210. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Tics Disorder in Children With ADHD Prevalence of Tics Disorder in Children With ADHD one year
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04935593 - Strengthening Social, Emotional and Behavioral Resilience N/A
Completed NCT05034198 - Remote Training in Rural Schools N/A
Completed NCT03614026 - Teachers and Parents as Partners During Middle School RCT N/A
Enrolling by invitation NCT05039164 - Evaluation of a Remote Training Strategy N/A
Enrolling by invitation NCT04869657 - Sustainment of Mental Health Supports N/A
Recruiting NCT05166694 - Evaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions N/A
Recruiting NCT05510401 - Evaluation of Safe Use of SECURIDRAP® SELFIA® N/A
Completed NCT03736057 - Genetic Evaluation for Medication Selection (GEMS) Study
Not yet recruiting NCT06232226 - Attention Deficit Hyperactivity Disorder N/A
Recruiting NCT05784818 - Up To Me: Erasing the Stigma of Mental Illness on College Campuses N/A
Terminated NCT03904784 - School Withdrawal in Adolescents
Recruiting NCT04675567 - The Safety-Net Approach N/A
Recruiting NCT06315114 - A Transdiagnostic Mentalization-based Intervention for Parents With Mental Disorders N/A
Completed NCT03799783 - The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders Phase 2
Completed NCT03116100 - Clinical Situations Leading to the Prescription of Neuroleptics by General Practitioner in the Elderly. Practice Survey
Completed NCT02707367 - Recovery Roadmap Phase II Small Business Innovation Research Grant N/A
Completed NCT03161171 - Parental Coping With Challenging Behavior in Mucopolysaccharidosis Type I-III N/A
Completed NCT00006446 - Preventing Problems in Children's Social Behavior N/A
Recruiting NCT04185896 - Perinatal Mental Health Care in Switzerland
Completed NCT03483896 - Pilot Study to Examine Health Effects of Daylight Exposure on Dementia Patients N/A