Tourette SyndromeNCT02153463
Activity in Tourette Syndrome
A study testing Physical Activity Counselling in people with Tourette Syndrome and Persistent Tic Disorder, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Tourette Syndrome, Persistent Tic Disorder
- What is being tested?
- Physical Activity Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tourette Syndrome, Persistent Tic Disorder
- Being tested
- Physical Activity Counselling
- Keywords
- Tourette Syndrome, Persistent Tic Disorder, Physical Activity, Quality of Life
- Medical subject headings
- Tourette Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity CounsellingBehavioural
Physical Activity Counselling weekly for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Activity Counselling | Experimental | Physical Activity Counselling weekly for 8 weeks Receives: Behavioral: Physical Activity Counselling |
| Standard Care | No intervention | Standard care with no change in medications for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Yale Global Tic Severity Scale.
Measured: 8 weeks
Secondary outcomes (1)
Change in The Gilles de la Tourette Syndrome Quality of Life Scale for children and adolescents
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asif Doja, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153463
- Sponsor's protocol ID
- 14/72X
- Status last verified
- Aug 2015
- First submitted
- 30 May 2014
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30487937
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Physical Activity in Children With Tics and Tourette Syndrome: Impact on Tic Severity and Quality of Life
- ClinicalTrials.gov ID
- NCT02153463
- Acronym / sponsor ID
- 14/72X
- Conditions
- Tourette Syndrome, Persistent Tic Disorder
- Keywords
- Tourette Syndrome, Persistent Tic Disorder, Physical Activity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity Counselling | Experimental | Behavioral: Physical Activity CounsellingPhysical Activity Counselling weekly for 8 weeks |
| Standard Care | No intervention | –Standard care with no change in medications for 8 weeks |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity CounsellingPhysical Activity Counselling weekly for 8 weeks | Behavioural | Activity Counselling |
Primary outcome
Decrease in Yale Global Tic Severity Scale.
Time frame: 8 weeks
1 secondary outcome
Change in The Gilles de la Tourette Syndrome Quality of Life Scale for children and adolescents
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
- Derived from this study: PubMed 30487937Doja 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Counselling in people with Tourette Syndrome and Persistent Tic Disorder, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in Yale Global Tic Severity Scale. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02153463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.