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

NCT03642951 | Withdrawn

• 1 other identifier: 14050210
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

magnetic; brain; stimulation

Outcome Measures

Primary Outcomes (1)

• Change in tic severity from baseline to 2 months post-treatment

  The investigators will assess reduction in tics with the Yale Global Tic Severity Scale. It is a rating that is based on a clinician-rated, semistructured interview that begins with a systematic inquiry of tic symptoms in the preceding week. Five index scores are obtained: Total Motor Tic Score, Total Phonic Tic Score, Total Tic Score, Overall Impairment Rating, and Global Severity Score. The Total Motor Tic Score is derived by adding the five motor tics items (range = 0-25); the Total Phonic Tic Score is derived by adding the five phonic tics items (range = 0-25). The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment). Finally, the Global Severity Score is a summation of the Total Motor Tic Score, Total Phonic Tic Score, and Overall Impairment Rating (range = 0-100). A higher score represents a worse outcome.

  Day of first treatment session, End of weeks 1 and 2, as well as 1 month and 2 months after treatment

Secondary Outcomes (2)

• Change in ADHD symptoms from baseline to two months post-treatment

  Day of first treatment session, End of weeks 1 and 2, as well as 1 month and 2 months after treatment

• Change in OCD symptoms from baseline to two months post-treatment

  Day of first treatment session, End of weeks 1 and 2, as well as 1 month and 2 months after treatment

Study Arms (2)

Active Treatment Group

ACTIVE COMPARATOR

Each patient will receive daily 40 min treatment five days per week for two weeks. The procedure during each treatment session will consist of positioning the device centered at 15% of the nasion-inion distance anterior to the Cz electrode placement in standard EEGs, with the patient relaxing in a chair. The stimulus parameters used will be 480 stimulus trains of 100 ms in duration, each train delivered every 5 s for total session duration of 40 min. The investigator will measure the subject for accurate placement of the device prior to each visit. Once the placement of the device is confirmed, the study technician administering the treatment will tum on the device using an app downloaded to an electronic device connected by Bluetooth to the device.

Device: Active Treatment

Sham Treatment Group

SHAM COMPARATOR

Each patient will receive daily 40 min treatment five days per week for two weeks. The procedure during each treatment session will consist of positioning the device centered at 15% of the nasion-inion distance anterior to the Cz electrode placement in standard EEGs, with the patient relaxing in a chair. The stimulus parameters used will be 480 stimulus trains of 100 ms in duration, each train delivered every 5 s for total session duration of 40 min. The investigator will measure the subject for accurate placement of the device prior to each visit. Once the placement of the device is confirmed, the study technician administering the treatment will tum on the device using an app downloaded to an electronic device connected by Bluetooth to the device. Note: While the device looks and is operated the same as the active device, subjects in this group will be stimulated with the placebo device so no active stimulation will be given.

Device: Sham Treatment

Interventions

Active Treatment DEVICE

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.

Also known as: Transcranial Rotating Permanent Magnet Stimulator (TRPMS)

Active Treatment Group

Sham Treatment DEVICE

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.

Also known as: Transcranial Rotating Permanent Magnet Stimulator (TRPMS) (SHAM)

Sham Treatment Group

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between the ages of 8 and 20 years old,
• A clinical diagnosis of TS as defined by the DSM V
• YGTSS score of 13 or more (performed at Visit 1).
• Patients with the following comorbidities: OCD, ADHD and anxiety disorders (as defined by the DSM V) will be allowed in the study. This will be assessed during Visit 1.

You may not qualify if:

• Any history of neurological, or psychiatric disorders including epilepsy and autism spectrum disorder, other than other than the allowed comorbidities (see above).
• An IQ less than 80, this will be assessed during Visit 1.
• The presence of metal implants or metallic devices in the head
• Any history of drug or alcohol abuse
• Any medication changes during the six weeks preceding enrollment or at any time during the 10-week course of the study

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• The Methodist Hospital Research Institute: collaborator
• Cornell University: collaborator

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (3)

• Robertson MM, Eapen V, Cavanna AE. The international prevalence, epidemiology, and clinical phenomenology of Tourette syndrome: a cross-cultural perspective. J Psychosom Res. 2009 Dec;67(6):475-83. doi: 10.1016/j.jpsychores.2009.07.010.

  PMID: 19913651 BACKGROUND

• Termine C, Selvini C, Rossi G, Balottin U. Emerging treatment strategies in Tourette syndrome: what's in the pipeline? Int Rev Neurobiol. 2013;112:445-80. doi: 10.1016/B978-0-12-411546-0.00015-9.

  PMID: 24295630 BACKGROUND

• Rossini PM, Rossi S. Transcranial magnetic stimulation: diagnostic, therapeutic, and research potential. Neurology. 2007 Feb 13;68(7):484-8. doi: 10.1212/01.wnl.0000250268.13789.b2.

  PMID: 17296913 BACKGROUND

Related Links

• Transcranial Brain Stimulation With Rapidly Spinning High-Field Permanent Magnets

MeSH Terms

Conditions

Tourette Syndrome

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

Study Officials

• Keith A Coffman, M.D.

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: August 22, 2018
• Study Start: July 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 15, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)