Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome

Summary

The investigators are investigating the effectiveness of a wearable multisite transcranial magnetic stimulation (mTMS) device that can deliver stimuli at multiple cortical sites simultaneously or sequentially for the treatment of Tourette Syndrome.

Conditions

• Tourette Syndrome

Interventions

DEVICE

Active Treatment

The study patients will be randomly assigned to two groups, each consisting of 10 patients: Group A - patients stimulated by devices marked A; Group B - patients stimulated by devices marked B. Since the devices used for actual and sham stimulation (placebo control) are similar in all respects including external appearance and the sound produced while activated, the technician(s), investigators and the patients will be completely blind to whether actual or sham stimuli are being delivered, i.e. whether Group A or Group B patients are receiving the actual stimuli. Indeed, both devices marked A\&B could be used to deliver either type of stimuli. Only the person who constructed the devices will know which is which. Therefore, this study will be a truly randomized double-blinded placebo-controlled clinical trial. In case of emergency, un-blinding of the device will be available to the study team via a sealed envelope, stored with the study documents, separate from the subjects study files.

DEVICE

Sham Treatment

The study patients will be randomly assigned to two groups, each consisting of 10 patients: Group A - patients stimulated by devices marked A; Group B - patients stimulated by devices marked B. Since the devices used for actual and sham stimulation (placebo control) are similar in all respects including external appearance and the sound produced while activated, the technician(s), investigators and the patients will be completely blind to whether actual or sham stimuli are being delivered, i.e. whether Group A or Group B patients are receiving the actual stimuli. Indeed, both devices marked A\&B could be used to deliver either type of stimuli. Only the person who constructed the devices will know which is which. Therefore, this study will be a truly randomized double-blinded placebo-controlled clinical trial. In case of emergency, un-blinding of the device will be available to the study team via a sealed envelope, stored with the study documents, separate from the subjects study files.

Sponsors & Collaborators

• The Methodist Hospital Research Institute

  collaborator OTHER

• Cornell University

  collaborator OTHER

• Children's Mercy Hospital Kansas City

  lead OTHER

Principal Investigators

• Keith A Coffman, M.D. · Children's Mercy Hospital Kansas City

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2022-06-30

Completion

2022-06-30

Countries

• United States

Study Locations