NCT03225430

Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders

Completed NA Last updated 15 July 2022

What this trial tests

NA trial testing Cognitive behavioural treatment for tics in Tic Disorder, Chronic Motor or Vocal in 144 participants. Completed in 1 September 2021.

Timeline

21 April 2016

Primary endpoint
1 September 2021

1 September 2021

Quick facts

Lead sponsor	Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	144
Start date	21 April 2016
Primary completion	1 September 2021
Estimated completion	1 September 2021
Sites	1 location across Canada

Drugs / interventions tested

• Cognitive behavioural treatment for tics
• Cognitive psychophysiological

Conditions studied

• Tic Disorder, Chronic Motor or Vocal — all drugs for Tic Disorder, Chronic Motor or Vocal →
• Tourette Syndrome in Children — all drugs for Tourette Syndrome in Children →
• Tourette Syndrome — all drugs for Tourette Syndrome →

Sponsor

Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Who can join

Adults 8 to 65, any sex, with Tic Disorder, Chronic Motor or Vocal or Tourette Syndrome in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is a randomized controlled trial to compare two behavioural treatments, namely CBIT and CoPs. This study would be the first head-to-head randomized trial between two established treatments rather than supportive counseling or wait-list control. Thirty-six adults and 36 children with TS/TD will be recruited into each of the two (CBIT, CoPs) modalities requiring a total recruitment of 72 adults and 72 children over 5 years, which permits, even for a small-medium effect size, a robust power calculation. Motor performance measures will give concurrent validity to changes pre-post in TS/TD motor processes. Recruitment of both males and females will permit sex comparisons. The participants meeting inclusion/exclusion criteria will be assessed at pre-post 1 month and 6 months following treatment on standardized tic scales and global assessment of functioning. Participants will be treated individually on a weekly basis by therapists with an allegiance to each modality and outcome assessed by masked evaluation. The treatments are manualized and will last 10 weeks with 4 weeks of home practice at post-treatment with 6-month follow-up assessment on all outcome measures, plus motor performance measures post-treatment. All treatment sessions will be audio-recorded and assessed with implementation of treatment integrity procedures scales. The hypotheses are that: (1) the CoPs group will show superiority in clinically significant improvement on standard tic scale score, global functioning and quality of life than the CBIT group; and (2) changes in recognized parameters on selected motor tests scored according to published norms will change towards normalization post CoPs but not post CBIT. The outcome data from the two treatments will be analyzed by a mixed linear model adaptation of repeated measures MANOVA and daily diary measures will allow for an additive time series design over the 10 weeks treatment session. This design will allow computation of the size of treatment effects at different stages of therapy. The study results will impact on the treatment of choice and access to treatment for tic disorders and on the conceptualization of tic disorders.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Capturing Subtle Neurocognitive Differences in Children with and without Tourette Syndrome through a Fine-Grained Analysis of Design Fluency Profiles.
   Tessier M, Desmarais A, Leclerc JB, Lavoie ME, et al · · 2022 · cited 6× · PMID 35407554 · DOI 10.3390/jcm11071946
2. Localising movement disorders in childhood.
   Bamford NS, McVicar K. · · 2019 · cited 3× · PMID 31653548 · DOI 10.1016/s2352-4642(19)30330-x