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Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

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ClinicalTrials.gov Identifier: NCT01823237
Recruitment Status : Recruiting
First Posted : April 4, 2013
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Cathrin Buetefisch, Emory University

Tracking Information
First Submitted Date  ICMJE March 19, 2013
First Posted Date  ICMJE April 4, 2013
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE February 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01823237 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia
Official Title  ICMJE Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Dystonia
Intervention  ICMJE Device: Transcranial Magnetic Stimulation
Other Name: TMS
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 29, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Farrah E Rink, MHSc 678-369-3152 frink@emory.edu
Contact: Cathrin Buetefisch, MD, PhD 404-712-1894 cbuetefisch@emory.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01823237
Other Study ID Numbers  ICMJE IRB00062538
DYST ( Other Identifier: Other )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cathrin Buetefisch, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cathrin Buetefisch, MD, PhD Emory University
PRS Account Emory University
Verification Date February 2019

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