Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Emory University
Sponsor:
Information provided by (Responsible Party):
Cathrin Buetefisch, Emory University
ClinicalTrials.gov Identifier:
NCT01823237
First received: March 19, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Dystonia
Device: Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of Increasing Motor Cortex Inhibition on Task Specific Dystonia

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Efficacy of TMS on task-specific focal hand dystonia [ Time Frame: Up to 3 weeks (2 visits) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 15
Study Start Date: February 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rTMS
rTMS condition, rTMS will be applied at 0.1-0.5 Hz frequency at a subthreshold intensity
Device: Transcranial Magnetic Stimulation
Other Name: TMS
Placebo Comparator: rTMS sham
Placebo condition will use a sham coil and apply a very small magnetic stimulus
Device: Transcranial Magnetic Stimulation
Other Name: TMS

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823237

Contacts
Contact: Farrah E Rink, MHSc 678-369-3152 frink@emory.edu
Contact: Cathrin Buetefisch, MD, PhD 404-712-1894 cbuetefisch@emory.edu

Locations
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Farrah E Rink, MHSc    678-369-3152    frink@emory.edu   
Principal Investigator: Cathrin Buetefisch, MD, PhD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Cathrin Buetefisch, MD, PhD Emory University
  More Information

No publications provided

Responsible Party: Cathrin Buetefisch, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT01823237     History of Changes
Other Study ID Numbers: IRB00062538, DYST
Study First Received: March 19, 2013
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Dystonia
Transcranial Magnetic Stimulation
Rehabilitation
Plasticity

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 August 26, 2014