rTMS to Reduce Tics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01258790
First received: December 10, 2010
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Tourette Syndrome
Device: Repetitive Transcranial Magnetic Stimulation (RTMS)
Device: Transcranial Magnetic Stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Transcranial Magnetic Stimulation to Reduce Tics

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Standard Clinical Scale [ Time Frame: two years ] [ Designated as safety issue: No ]

    The primary outcome will be tic percentage reduction based on the YGTSS, the standard clinical tic severity scale.

    Routine descriptive statistics will be used to describe pre- and post-TBS clinical rating scores. Estimates of between group differences, with 95% confidence intervals, will be performed. Parametric (t-test) or nonparametric (Wilcoxon-Mann-Whitney) group mean or median comparisons will be used, as appropriate, depending on the characteristics of the distribution. Two sided tests will be used, with p < 0.05 considered significant.



Secondary Outcome Measures:
  • Standard Clinical Scales [ Time Frame: two years ] [ Designated as safety issue: No ]
    Secondary outcome(s) will be clinical rating scales from the Clinical Global Impression22, Gilles de la Tourette syndrome-quality of life scale23, Premonitory Urge for Tics Scale25, DuPaul ADHD scale26 or Adult ADHD Self-Report Scale27 and Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)28 or Yale-Brown Obsessive Compulsive Scale (Y-BOCS)29, 30 and Modified Rush Video-Based Tic Rating Scale31, 32.


Enrollment: 12
Study Start Date: November 2010
Study Completion Date: March 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Transcranial Magnetic Stimulation Device: Repetitive Transcranial Magnetic Stimulation (RTMS)
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
Other Name: rTMS, TBS, TMS
Device: Transcranial Magnetic Stimulation
Each session will last at most 180 minutes and the motor responses to TMS are recorded with surface EMG electrodes taped to the skin. The signal is amplified, and filtered (100/1000 Hz) (Coulbourn Instruments, Allentown, PA) before being digitized at 2 kHz and stored for off-line analysis using Signal® software and a Micro1401 interface (Cambridge Electronic Design, Cambridge, UK).

Detailed Description:

Tourette syndrome (TS) is characterized by multiple motor and phonic tics. Current understanding of tic generation is thought involve the cortico-basal-thalamic-cortical circuit. At this time, only two medications are FDA-approved for tic treatment, while many more are used in an off-label fashion with only partial success. Despite multiple approaches for tic suppression, patients with severe tics are often left with inadequate relief. Repetitive Transcranial Magnetic Stimulation (RTMS) is a new technology which allows for noninvasive stimulation of the brain. In few pilot studies, RTMS reduced tic severity when targeting the Supplementary Motor Area (SMA). In this study, we propose to use a specific paradigm of RTMS called Continuous Theta Burst Stimulation (cTBS) over SMA to treat pediatric and adult patients with tics. We will utilize functional MRI (fMRI) to identify each subject's SMA for individualized stimulation. We hypothesize that this stimulation technique can reduce tic severity when compared to sham stimulation. This proposal is novel because 1) cTBS is offered as a new RTMS paradigm to reduce tics and 2) combination of RTMS and fMRI allows us to investigate the effects of cortical stimulation on the neural correlates of tic generation.

  Eligibility

Ages Eligible for Study:   10 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1. Children or adults with Tourette Syndrome, tic disorder, chronic motor or vocal tics disorder ages 10 to 60 years.

2. 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.

4. If subject receives botulinum toxin injection for tic management, the injection must be at least twelve weeks prior to the day of the study.

5. After the TBS sessions, no tic-suppression medications can be changed for at least one week.

6. 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.

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Exclusion Criteria:1. Implanted brain stimulator, vagal nerve stimulator, VP shunt, aneurysm clip, cardiac pacemaker, or implanted medication port.

2. 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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258790

Locations
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Steve Wu, MD Cincinnati Children's
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01258790     History of Changes
Other Study ID Numbers: IRB #: 2010-2689
Study First Received: December 10, 2010
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
TS
tics
tourette

Additional relevant MeSH terms:
Tourette Syndrome
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
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014