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Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

This study is currently recruiting participants.
Verified October 2017 by Cathrin Buetefisch, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823237
First Posted: April 4, 2013
Last Update Posted: October 11, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cathrin Buetefisch, Emory University
March 19, 2013
April 4, 2013
October 11, 2017
February 2013
December 2017   (Final data collection date for primary outcome measure)
Efficacy of TMS on task-specific focal hand dystonia [ Time Frame: Up to 3 weeks (2 visits) ]
We will assess the effects of rTMS using objective, subjective and kinematic measures. This is a pilot study and will require further research to assess the long-term effects of repetitive TMS on task-specific focal hand dystonia.
Same as current
Complete list of historical versions of study NCT01823237 on ClinicalTrials.gov Archive Site
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Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia
Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia
Dystonia is a disease where muscles in the affected body part are abnormally active. This may result in abnormal postures. The underlying mechanisms are not known. One proposed mechanism is located in the motor area of the brain that controls the coordination of muscles, called the motor cortex. It is well known that the motor area of one hemisphere of the brain (motor cortex) controls the movement of the opposite side of the body. When people perform tasks such as picking up an object or writing there are mechanisms in motor cortex that focus the level of activity so that they can do these tasks with a high level of precision. Focusing activity in motor cortex seems to be disturbed in people with dystonia. Transcranial magnetic stimulation (TMS) is a device that allows the non-invasive stimulation of the brain. When applied to the motor cortex it can upregulate or down regulate its activity. In the present study the investigators will conduct experiments on subjects with task specific focal hand dystonia (such as writers cramp) using TMS to decrease unwanted motor activity. The investigators will assess the effects of this intervention using objective, subjective and kinematic measures. This is a pilot study and will require further research to assess the long-term effects of repetitive TMS on task-specific focal hand dystonia.
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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Dystonia
Device: Transcranial Magnetic Stimulation
Other Name: TMS
  • Active Comparator: rTMS
    rTMS condition, rTMS will be applied at 0.1-0.5 Hz frequency at a subthreshold intensity
    Intervention: Device: Transcranial Magnetic Stimulation
  • Placebo Comparator: rTMS sham
    Placebo condition will use a sham coil and apply a very small magnetic stimulus
    Intervention: Device: Transcranial Magnetic Stimulation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
April 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • If you are treated with Botulinum toxin, the testing should be done at least 3 months after your last Botulinum toxin injections.
  • Adult patients with task-specific dystonia strictly confined to one hand since the onset of symptoms
  • No dystonic movements at rest
  • Normal MRI scan of the brain as per clinical record
  • No intake of CNS active drugs that may interfere with the study
  • No contraindication for TMS
  • Ability to perform the selective task
  • No other neurological disease that may interfere with the study
  • Ability to give informed consent

Exclusion Criteria:

  • You have a history of migraines
  • You have a diagnosed seizure disorder
  • You take any Central Nervous System CNS active drugs, such as benzodiazepines, Lorazepam, Baclofen, SSRI's and other anti-depressants, etc. that may interfere with the response to TMS.
  • You have any clips or implants in your head
  • You have a pacemaker
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact: Farrah E Rink, MHSc 678-369-3152 frink@emory.edu
Contact: Cathrin Buetefisch, MD, PhD 404-712-1894 cbuetefisch@emory.edu
United States
 
 
NCT01823237
IRB00062538
DYST ( Other Identifier: Other )
No
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Cathrin Buetefisch, Emory University
Emory University
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Principal Investigator: Cathrin Buetefisch, MD, PhD Emory University
Emory University
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP