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Theta-burst Transcranial Magnetic Stimulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Terence Sanger, University of Southern California
ClinicalTrials.gov Identifier:
NCT00878787
First received: March 20, 2009
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

Theta-burst transcranial magnetic stimulation (TBS) is a type of repetitive transcranial magnetic stimulation (rTMS) method that reduces the excitability of a small region of brain for less than one hour. Since dystonia and spasticity may be associated with increased excitability of motor cortex, we expect that by reducing the excitability of motor cortex with TBS we will temporarily improve these symptoms and hopefully open avenues in the future for the use of TBS as a new, non-invasive therapeutic intervention to aid in physical therapy and symptom amelioration of dystonia and spasticity. We will test for motor improvement during the hour immediately following TBS using tests of muscle function and quality of limb movement.


Condition Intervention
Dystonia
 Device: Transcranial magnetic stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Theta-burst Transcranial Magnetic Stimulation for the Treatment of Childhood Dystonia and Spasticity

Resource links provided by NLM:

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • surface EMG overflow and control [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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  Eligibility

Ages Eligible for Study:   2 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:1. Dystonia affecting one or both hands or arms, and/or spasticity affecting one or both hands/arms 2. Age 2 years to 29 years 3. Sufficient cognitive function to attempt isolated finger movements

Exclusion Criteria:1. any metallic implants in the head or neck 2. seizure within 2 years of study entry, or prior history of status epilepticus outside the newborn period.

3. deep-brain stimulator, vagal nerve stimulator, pacemaker, intrathecal baclofen pump, or other implanted electrical device.

4. prior neurosurgical procedure 5. migraine disorder 6. known cardiac arrhythmia, or history of syncope 7. use of tricyclic antidepressants or neuroleptic medications during the study 8. use or requirement for medications to treat seizures

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878787

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Terence D. Sanger Stanford University
  More Information

No publications provided

Responsible Party: Terence Sanger, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00878787     History of Changes
Other Study ID Numbers: SU-03162009-1999, 11954
Study First Received: March 20, 2009
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013