TICS: Transcranial Magnetic Stimulation for Intervening in Children With Tourette's Syndrome (CIHR)
TICS-CIHR
1 other identifier
interventional
50
1 country
1
Brief Summary
Tourette's Syndrome (TS) is characterized by repetitive movements and vocalizations called tics. Due to the suffering caused by TS, children and adolescents often require treatment for their tics. The investigators' research focuses on developing novel repetitive transcranial magnetic stimulation (rTMS) interventions for child and adolescent neuropsychiatric disorders. In this project, the investigators will determine the effect of pairing 3 weeks of rTMS and HRT on tic severity and plasticity as indexed by supplementary motor area (SMA) y-aminobutyric acid (GABA) concentration and functional connectivity of the SMA to the primary motor cortex (M1) in children and adolescents with TS. Children (N = 50, 6-18 years) with TS will be randomized to either a (1) rTMS+HRT arm, or (2) sham rTMS+HRT. Outcome measures will examine tic severity (primary), brain chemistry and function (secondary) at baseline and then at week 7. The investigators' proposed aims are: (Aim 1) To determine the effect of paired rTMS and HRT on tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) by comparing it to sham rTMS + HRT. 1-1: The investigators hypothesize that tic severity will decrease from baseline to post-treatment. 1-2: The investigators also hypothesize that the reduction in tic severity will be greater in the paired treatment group (rTMS+HRT \> Sham rTMS+HRT). (Aim 2) To determine the effect of paired rTMS and HRT on brain plasticity compared to sham rTMS + HRT. 2-1: The investigators hypothesize that patients treated with the paired rTMS and HRT will have a greater increase in GABA concentration comparted to sham and HRT. 2-2: The investigators also hypothesize that functional connectivity between the SMA and M1 will be greater with paired treatment (rTMS+HRT \> Sham rTMS+HRT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedNovember 10, 2021
November 1, 2021
2.7 years
February 11, 2019
November 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Yale Global Tic Severity Scale Total Tic score (YGTSS)
30% reduction in Yale Global Tic Severity Scale Total Tic score (YGTSS) (\~9 point reduction). A higher score on all scales suggests a more severe tics. The YGTSS provides two tic severity scores: 1. Total Motor (0 to 25) 2. Total Phonic (0 to 25) These are summed to form the Total Tic Severity Score (0 to 50). This is the measure for the primary outcome variable. There is also the separate Impairment Dimension Score (0 to 50). The total score is hence 0 to 100 (sum of Total Tic Severity Score and Impairment Dimension Score).
Baseline to week 7
Secondary Outcomes (2)
Supplementary Motor Area (SMA) GABA concentration as measured by LCModel (Institutional Units)
Baseline to week 7
Functional connectivity of the Supplementary Motor Area (SMA) and the dominant Primary Motor Cortex (M1)
Baseline to week 7
Other Outcomes (1)
Yale Global Tic Severity Scale Total Tic score (YGTSS) post CBIT
Baseline to week 11
Study Arms (2)
rTMS + CBIT
EXPERIMENTALRepetitive transcranial magnetic stimulation (rTMS) and Comprehensive Behavioural Intervention for Tics (CBIT)
Sham rTMS + CBIT
ACTIVE COMPARATORSham repetitive transcranial magnetic stimulation (rTMS) and Comprehensive Behavioural Intervention for Tics (CBIT)
Interventions
Repetitive Transcranial Magnetic Stimulation (rTMS) parameters are: intensity 100% resting motor threshold (RMT), frequency 1Hz, duration = 30 minutes (1800 stimulations; 900 per side), target - the supplementary motor area (SMA). Treatments occur on weekdays (T - F) for four weeks (20 total). The Comprehensive Behavioral Intervention for Tics (CBIT) will be completed over eight sessions that will average 60 minutes in duration. First, participants will undergo awareness training. Participants will then be introduced to competing response training, which involves performing a voluntary behaviour designed to disrupt the execution of the tic. The eight sessions will occur on Mondays, once a week for six weeks and then on weeks 8 and 10.
Sham rTMS (sham coil) will be paired with CBIT. Sham rTMS will be delivered over the same time-frame as above. CBIT will be identical to the above.
Eligibility Criteria
You may qualify if:
- Diagnosis of Tourette's syndrome
- IQ greater than 80
- English fluency (to enable assent and consent).
You may not qualify if:
- Diagnosis of mania or schizophrenia
- Impediments to TMS or MRI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Related Publications (1)
Kahl CK, Swansburg R, Kirton A, Pringsheim T, Wilcox G, Zewdie E, Harris A, Croarkin PE, Nettel-Aguirre A, Chenji S, MacMaster FP. Targeted Interventions in Tourette's using Advanced Neuroimaging and Stimulation (TITANS): study protocol for a double-blind, randomised controlled trial of transcranial magnetic stimulation (TMS) to the supplementary motor area in children with Tourette's syndrome. BMJ Open. 2021 Dec 24;11(12):e053156. doi: 10.1136/bmjopen-2021-053156.
PMID: 34952879DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank P MacMaster, PhD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Eligible subjects will be randomly assigned to receive one of the two treatment regimens in a 1:1 ratio. Dr. Nettel-Aguirre will generate the sequence with random sized blocks of 2,4 and 6 and use the REDCap randomization module for recruiters to access the allocation for the subjects. The algorithm will stratify each by sex and age group (6-10, 11-14, 15-18 years). Dr. Zewdie will set up the rTMS accordingly for active or sham delivery. Participants and their parents will be blind to group status regarding sham vs. active rTMS. Dr. Wilcox, and all raters responsible for clinical evaluation under Dr. Wilcox's supervision, will also be blinded to group status.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 11, 2019
First Posted
February 19, 2019
Study Start
September 1, 2019
Primary Completion
May 1, 2022
Study Completion
November 1, 2022
Last Updated
November 10, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Study protocol, SAP, and ICF is open to be shared now. De-identified data will be shared after we submitted our main papers. This is estimated in 2025.
- Access Criteria
- Email for permission from PI of project.
Only de-identified data would be shared.