- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02153463
Activity in Tourette Syndrome
Enhancing Physical Activity in Children With Tics and Tourette Syndrome: Impact on Tic Severity and Quality of Life
Tics are brief repetitive movements or vocalizations. Gilles de la Tourette's syndrome (TS) is a disorder characterized by recurrent motor and vocal tics. Tourette syndrome and tic disorders affect up to 8% of children. Peak severity of tic disorders occurs between the ages of 8 to 12 years, therefore during childhood and adolescence the most significant impacts are felt. The quality of life of young people with tics is lower than their peers' and tic severity predicts lower quality of life. Studies have also shown negative social perception toward children with tics.
Approximately 50% of patients with Tourette syndrome will have other diagnoses including attention deficit hyperactivity disorder (ADHD), obsessive compulsive disorder, anxiety and depression. Studies have shown improvements in ADHD with physical activity. ADHD and tic disorders are thought to involve the same areas of the brain; thus it is possible that tics might also improve with physical activity. However, no studies to date have examined this. The investigators predict that by implementing a motivational physical activity program, in conjunction with physical activity counseling, the investigators will be able to increase levels of physical activity in children with tics and Tourette syndrome, with a positive impact on tic severity.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 7G2
- Children's Hospital of Eastern Ontario
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants are between 8-16 years of age.
- Participants are required to have a diagnosis of either Tourette Syndrome or Persistent (Chronic) Motor of Vocal Tic Disorder as per the DSM V.
- Participants must be ambulatory.
- Participants and parents must understand English or French.
- Participants must be able and willing to complete the questionnaires.
- Participants cannot have any changes to their medication for tics, or any other psychotropic medications for 4 weeks prior to and for the entire duration of the study
Exclusion Criteria:
- Participants who cannot ambulate independently.
- Participants who are not permitted to participate in physical education class at school.
- Participants or families who are not willing to be randomly assigned to a study group.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Activity Counselling
Physical Activity Counselling weekly for 8 weeks
|
Physical Activity Counselling weekly for 8 weeks
|
|
No Intervention: Standard Care
Standard care with no change in medications for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Decrease in Yale Global Tic Severity Scale.
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in The Gilles de la Tourette Syndrome Quality of Life Scale for children and adolescents
Time Frame: 8 weeks
|
8 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in PedsQL 4.0 measure
Time Frame: 8 weeks
|
8 weeks
|
|
Change in KidScreen-27
Time Frame: 8 weeks
|
8 weeks
|
|
Chang in The Children's Self-perceived Adequacy and Predilection for Physical Activity Questionnaire
Time Frame: 8 Weeks
|
8 Weeks
|
|
Change in step count via pedometer
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Syndrome
- Tourette Syndrome
- Tic Disorders
- Tics
Other Study ID Numbers
- 14/72X
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tourette Syndrome
-
Dongdong QinNot yet recruiting
-
University of UtahRecruitingTics | Tourette Syndrome in Children | Tourette Syndrome in Adolescence | Tourette DisorderUnited States
-
Children's Hospital Medical Center, CincinnatiTourette Association of AmericaCompletedTourette Syndrome | Tourette Syndrome in Children | Tourette Syndrome in Adolescence | Tourette Syndrome, Modifier ofUnited States
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Ministry of Health, ItalyCompletedTourette Syndrome | Tourette's Syndrome | Tourette Disorder | Gilles de la Tourette SyndromeItaly
-
Tasly Pharmaceuticals, Inc.Not yet recruitingTourette Syndrome in Children | Tourette Syndrome in AdolescenceUnited States
-
Emalex Biosciences Inc.CompletedTourette Syndrome in Children | Tourette Syndrome in AdolescenceUnited States, Poland, France, Canada, Germany
-
Vanderbilt University Medical CenterCompletedTourette Syndrome | Tourette Syndrome in Children | Tourette Syndrome in AdolescenceUnited States
-
Johns Hopkins UniversityCompletedTourette Syndrome in Children | Tourette Syndrome in Adolescence | Habit Reversal Training | TicUnited States
-
Tel Aviv Medical CenterUnknownTourette Syndrome in Children | Tourette Syndrome in Adolescence | Chronic Tic DisorderIsrael
-
University of UtahRecruitingClinical Characteristics and Temporal Properties of Individual Tics in Persistent Tic Disorder (PTD)Tourette Syndrome | Tic Disorders | Tics | Tourette Syndrome in Children | Tourette Syndrome in Adolescence | Vocal Tic | Motor Tic | Tics/TremorUnited States
Clinical Trials on Physical Activity Counselling
-
Children's Hospital of Eastern OntarioLondon Health Sciences Centre; Stollery Children's Hospital; Ontario Child Health... and other collaboratorsCompletedCongenital Heart DiseaseCanada
-
KU LeuvenFire Stress TeamNot yet recruitingPTSD | Stress, Psychological | Depressive Symptoms | Anxiety Disorders and Symptoms
-
University of OttawaHopital MontfortCompletedPhysical InactivityCanada
-
McMaster UniversityThe Ottawa Hospital Academic Medical Association; Hamilton Academic Health... and other collaboratorsCompleted
-
University of Southern DenmarkMunicipality of SønderborgCompleted
-
Istanbul UniversityCompletedObesity | Physical Activity | Exercise | Bariatric SurgeryTurkey
-
Universidad Autonoma de MadridCompletedLow Back Pain | Physical ActivitySpain
-
Odense University HospitalAarhus University HospitalCompletedGestational Weight Gain | Maternal Obesity | Obstetric ComplicationsDenmark
-
King Saud UniversityNot yet recruitingPreDiabetes | Marker; Structural
-
University of Southern DenmarkDK-Sønderborg MunicipalityCompleted