Recruiting

TMS

Sponsor:

University of Calgary

Code:

NCT03844919

Conditions

Tic Disorders

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Interventions

rTMS + CBIT

Sham rTMS + CBIT

Study Details

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).

Conditions

Tic Disorders

Study ID

NCT03844919

Start date

Sep 1, 2019

Status verified date

Nov, 2021

Completion date

Nov 1, 2022

Anticipated

Primary completion date

May 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of Tourette's syndrome
2. IQ greater than 80
3. English fluency (to enable assent and consent).

Exclusion Criteria:

1. Diagnosis of mania or schizophrenia
2. Impediments to TMS or MRI.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rTMS + CBIT

Repetitive transcranial magnetic stimulation (rTMS) and Comprehensive Behavioural Intervention for Tics (CBIT)

active comparator: Sham rTMS + CBIT

Sham repetitive transcranial magnetic stimulation (rTMS) and Comprehensive Behavioural Intervention for Tics (CBIT)

Interventions

rTMS + CBIT

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 + CBIT

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.

Primary outcome measure

  • Yale Global Tic Severity Scale Total Tic score (YGTSS) [ Time Frame: Baseline to week 7 ]

Central Contacts and Locations

Central contacts

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Frank P MacMaster, PhD

403-955-2784fmacmast@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Nov 10, 2021

Last verified

Nov, 2021

Keywords

  • Children
  • Adolescent
  • CBIT
  • Transcranial magnetic stimulation
  • Comprehensive Behavioral Intervention for Tics
  • rTMS
  • TMS
  • MRI
  • Tourette's Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2021-11-10.