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Theta-burst Transcranial Magnetic Stimulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00878787
First Posted: April 9, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Terence Sanger, University of Southern California
  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: None (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:


Further study details as provided by Terence Sanger, University of Southern California:

Primary Outcome Measures:
  • surface EMG overflow and control [ Time Frame: 1 hour ]

Enrollment: 5
Study Start Date: January 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Theta-burst Trancranial Magnetic Stim Device: Transcranial magnetic stimulation

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Terence Sanger, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00878787     History of Changes
Other Study ID Numbers: SU-03162009-1999
First Submitted: March 20, 2009
First Posted: April 9, 2009
Last Update Posted: October 12, 2017
Last Verified: May 2014

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