Repetitive Transcranial Magnetic Stimulation to Reduce Tics

NCT01258790 | Completed Results DMC

• 1 other identifier: IRB #: 2010-2689
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aim1: Using a paradigm of Transcranial Magnetic Stimulation called Continuous Theta Burst Stimulation (cTBS) to reduce tics in Tourette Syndrome subjects Hypothesis1: cTBS, compared to sham stimulation, will reduce tic severity by at least 25% as measured by the Yale Global Tic Severity Scale Specific Aim2: Using cTBS to further understand neural correlates of tic generation Hypothesis2: Functional MRI BOLD signal activation pattern will change after cTBS and this change will correlate with clinical improvement in tic severity

Conditions

Tourette Syndrome

Keywords

TS; tics; tourette

Outcome Measures

Primary Outcomes (1)

• Yale Global Tic Severity Scale

  The tic severity score based on Yale Global Tic Severity Scale ranges from 0 - 50. A person who has no tics would have a score of 0. High score means a person has severe tics.

  1 week

Study Arms (2)

Sham Repetitive Transcranial Magnetic Stimulation

SHAM COMPARATOR

Eight sessions of Repetitive Transcranial Magnetic Stimulation, in the form of Continuous Theta Burst Stimulation, was delivered over the Supplementary Motor Area over 2 days using a Sham TMS coil.

Device: Sham Repetitive Transcranial Magnetic Stimulation

Active Repetitive Transcranial Magnetic Stimulation

EXPERIMENTAL

Eight sessions of Repetitive Transcranial Magnetic Stimulation, Continuous Theta Burst Stimulation, was delivered over the Supplementary Motor Area over 2 days using an Active Magstim Figure-8 TMS coil.

Device: Active Repetitive Transcranial Magnetic Stimulation

Interventions

Sham Repetitive Transcranial Magnetic Stimulation DEVICE

Repetitive Transcranial Magnetic Stimulation (RTMS) is a relatively new technology that allows for targeted noninvasive stimulation of the brain. RTMS is currently FDA-cleared for the treatment of refractory depression. It is also used experimentally to treat seizures, spasticity, dystonia and other neuropsychiatric conditions. The Sham intervention uses a sham magnetic coil.

Also known as: rTMS, TBS, TMS

Sham Repetitive Transcranial Magnetic Stimulation

Active Repetitive Transcranial Magnetic Stimulation DEVICE

Repetitive Transcranial Magnetic Stimulation (RTMS) is a relatively new technology that allows for targeted noninvasive stimulation of the brain. RTMS is currently FDA-cleared for the treatment of refractory depression. It is also used experimentally to treat seizures, spasticity, dystonia and other neuropsychiatric conditions. The Active intervention uses an active magnetic coil.

Also known as: rTMS, TBS, TMS

Active Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Current tics with Yale Global Tic Severity Scale (YGTSS) score \> 10. 3. If subject is on tic-suppressing medication(s) at the time of recruitment, no medication or dose changes allowed within the past seven days.
• \. If subject receives botulinum toxin injection for tic management, the injection must be at least twelve weeks prior to the day of the study.
• \. After the TBS sessions, no tic-suppression medications can be changed for at least one week.
• \. All patients ages 10 to 60 years old with Tourette Syndrome, tic disorder, chronic motor or vocal tics disorder will be offered to participate in the study. If the patient decides to participate in the study, our study coordinator will obtain informed consent from the adult participant, or at least one parent of the pediatric participant. The consent form is written in English; the form is also written in a manner understandable by the person signing the form. The adult participant, the parent(s) of participant or the pediatric participant does not have to make a decision at the time of clinic visit, thus, minimizing coercion to participate.

You may not qualify if:

• \. Prior ischemic or hemorrhagic stroke or traumatic brain injury. 3. History of seizure or epilepsy 4. If female, pregnant or sexually active and not using birth control. Abstinence will be permitted at the discretion of the TS clinicians, consistent with other IRB approved studies involving this population.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tics

Interventions

Transcranial Magnetic Stimulation

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

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Steve Wu, MD
• Organization: Cincinnati Children's Hospital Medical Center

steve.wu@cchmc.org

513-636-4222

Study Officials

• Steve Wu, MD

  Cincinnati Children's

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 13, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: July 1, 2014
• Results First Posted: July 1, 2014

Record last verified: 2014-05

Locations

US (1)