Trial record 9 of 96 for:    tourette's

Activity in Tourette Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Children's Hospital of Eastern Ontario
Sponsor:
Information provided by (Responsible Party):
Asif Doja, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT02153463
First received: May 30, 2014
Last updated: June 2, 2014
Last verified: May 2014
  Purpose

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 Intervention
Tourette Syndrome
Persistent Tic Disorder
Behavioral: Physical Activity Counselling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Decrease in Yale Global Tic Severity Scale. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in The Gilles de la Tourette Syndrome Quality of Life Scale for children and adolescents [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in PedsQL 4.0 measure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in KidScreen-27 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Chang in The Children's Self-perceived Adequacy and Predilection for Physical Activity Questionnaire [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • Change in step count via pedometer [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02153463

Contacts
Contact: Asif Doja, MD 613-737-7600 ext 3358 adoja@cheo.on.ca

Locations
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 7G2
Contact: Asif Doja, MD    613-737-7600 ext 3358    adoja@cheo.on.ca   
Sub-Investigator: Daniela Pohl, MD         
Principal Investigator: Asif Doja, MD         
Sub-Investigator: Patricia Longmuir, PhD         
Sub-Investigator: Ammar Bookwala, BSc         
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
  More Information

No publications provided

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
Study First Received: May 30, 2014
Last Updated: June 2, 2014
Health Authority: Canada: Institutional Review Board

Keywords provided by Children's Hospital of Eastern Ontario:
Tourette Syndrome
Persistent Tic Disorder
Physical Activity
Quality of Life

Additional relevant MeSH terms:
Tourette Syndrome
Tic Disorders
Tics
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 23, 2014