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Activity in Tourette Syndrome

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ClinicalTrials.gov Identifier: NCT02153463
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):
Asif Doja, Children's Hospital of Eastern Ontario

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Tourette Syndrome Persistent Tic Disorder Behavioral: Physical Activity Counselling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Physical Activity in Children With Tics and Tourette Syndrome: Impact on Tic Severity and Quality of Life
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Activity Counselling
Physical Activity Counselling weekly for 8 weeks
Behavioral: Physical Activity Counselling
Physical Activity Counselling weekly for 8 weeks

No Intervention: Standard Care
Standard care with no change in medications for 8 weeks



Primary Outcome Measures :
  1. Decrease in Yale Global Tic Severity Scale. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Change in The Gilles de la Tourette Syndrome Quality of Life Scale for children and adolescents [ Time Frame: 8 weeks ]

Other Outcome Measures:
  1. Change in PedsQL 4.0 measure [ Time Frame: 8 weeks ]
  2. Change in KidScreen-27 [ Time Frame: 8 weeks ]
  3. Chang in The Children's Self-perceived Adequacy and Predilection for Physical Activity Questionnaire [ Time Frame: 8 Weeks ]
  4. Change in step count via pedometer [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153463


Locations
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Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 7G2
Sponsors and Collaborators
Children's Hospital of Eastern Ontario

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Asif Doja, Assistant Professor, Associate Investigator, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02153463     History of Changes
Other Study ID Numbers: 14/72X
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015
Keywords provided by Asif Doja, Children's Hospital of Eastern Ontario:
Tourette Syndrome
Persistent Tic Disorder
Physical Activity
Quality of Life
Additional relevant MeSH terms:
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Tourette Syndrome
Tic Disorders
Tics
Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms