Transcranial Magnetic Stimulation for Children With Tourette's Syndrome

NCT02356003 | Completed Results

• 1 other identifier: REB14-1839
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Tics are the core symptom of Tourette syndrome. These are repetitive, sudden, semi-voluntary movements or sounds. In some children, these tics can be especially bad and require treatment, however, options are limited. It is only with time and practice that youth with Tourette syndrome are better able to suppress their tics. For these reasons, new interventions are needed. The investigators will target a brain region involved in tics called the supplementary motor area. Using low frequency repetitive transcranial magnetic stimulation, the investigators will inhibit the activity, in a similar way to the tic suppression that develops with age. The investigators propose the following objectives: (Aim 1) The investigators hypothesize that Tourette syndrome symptom severity (as measured by the Yale Global Tic severity Scale) will decrease with low frequency repetitive transcranial magnetic stimulation targeting the supplementary motor area. (Aim 2) The investigators further hypothesize that improvement in Tourette syndrome symptoms will be moderated by low frequency repetitive transcranial magnetic stimulation induced changes in GABA and glutamate in the supplementary motor area, and changes in the functional connectivity between the supplementary motor area and primary motor cortex. Eleven children (7-12 years of age) with Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation (five times a week for three weeks). After the three weeks, they will look for changes in tic severity and brain chemistry and function. By developing a novel avenue for treating Tourette syndrome, they can directly impact the care of children by reducing the severity of tics and improving quality of life.

Conditions

Tourette Syndrome

Keywords

Tourette Syndrome; Children; Tics

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Scale

  Measure of tic severity using the Yale Global Tic Severity Scale (YGTSS). This is the standard measure for studies of Tourette's syndrome. The Global Severity Score has a range of 0- 100. A higher score on all scales suggests greater severity of tics.

  Four weeks

Secondary Outcomes (2)

• Glutamate Concentration

  Four weeks

• Functional Connectivity

  Four weeks

Study Arms (1)

Low frequency rTMS

EXPERIMENTAL

Eleven children (7-12 years of age) with Tourette syndrome will be undergo low frequency repetitive transcranial magnetic stimulation (5 times a week for three weeks).

Device: Low frequency repetitive transcranial magnetic stimulation

Interventions

Low frequency repetitive transcranial magnetic stimulation DEVICE

Baseline high-resolution anatomical magnetic resonance images will allow individualized neuronavigation (Brainsight 2, Rogue Research, Montreal QC) to co-register the transcranial magnetic stimulation Airfilm coil (Magistim, UK) precisely to the supplementary motor area as defined by functional magnetic resonance imaging. Interventional low frequency repetitive transcranial magnetic stimulation parameters will be: intensity 100% resting motor threshold, frequency 1 Hz, duration = 20 minutes (1200 stimulations). Treatments will occur on each weekday at the same time of day for three weeks (15 total). These are standard parameters for low frequency repetitive transcranial magnetic stimulation and are well tolerated in children.

Low frequency rTMS

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males
• Right-handed

You may not qualify if:

• Female
• Left-handed
• Comorbid Attention Deficit Hyperactivity Disorder

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Tourette Syndrome; Tics

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a pilot open label trial of rTMS and as such subject to the standard limitations of all pilot intervention studies.

Results Point of Contact

• Title: Frank MacMaster
• Organization: University of Calgary

fmacmast@ucalgary.ca

403-955-2784

Study Officials

• Frank p MacMaster, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2015
• First Posted: February 4, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 29, 2020
• Results First Posted: April 13, 2020

Record last verified: 2020-10

Locations

CA (1)