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

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 1, 2019

Primary Completion Date

June 30, 2022

Study Completion Date

June 30, 2022

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.

Trial Locations (1)

64108

Children's Mercy Hospital, Kansas City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

The Methodist Hospital Research Institute

OTHER

collaborator

Cornell University

OTHER

lead

Children's Mercy Hospital Kansas City

OTHER