NCT02153463

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

7 months

First QC Date

May 30, 2014

Last Update Submit

August 5, 2015

Conditions

Keywords

Tourette SyndromePersistent Tic DisorderPhysical ActivityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Decrease in Yale Global Tic Severity Scale.

    8 weeks

Secondary Outcomes (1)

  • Change in The Gilles de la Tourette Syndrome Quality of Life Scale for children and adolescents

    8 weeks

Other Outcomes (4)

  • Change in PedsQL 4.0 measure

    8 weeks

  • Change in KidScreen-27

    8 weeks

  • Chang in The Children's Self-perceived Adequacy and Predilection for Physical Activity Questionnaire

    8 Weeks

  • +1 more other outcomes

Study Arms (2)

Activity Counselling

EXPERIMENTAL

Physical Activity Counselling weekly for 8 weeks

Behavioral: Physical Activity Counselling

Standard Care

NO INTERVENTION

Standard care with no change in medications for 8 weeks

Interventions

Physical Activity Counselling weekly for 8 weeks

Activity Counselling

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 7G2, Canada

Location

Related Publications (1)

  • Doja A, Bookwala A, Pohl D, Rossi-Ricci A, Barrowman N, Chan J, Longmuir PE. Relationship Between Physical Activity, Tic Severity and Quality of Life in Children with Tourette Syndrome. J Can Acad Child Adolesc Psychiatry. 2018 Nov;27(4):222-227. Epub 2018 Nov 1.

MeSH Terms

Conditions

Tourette SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Associate Investigator

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 3, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations