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Role of Ipsilateral Motor Cortex in Executing Movements With Increasing Demand on Precision (RIMC)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01726218
First Posted: November 14, 2012
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. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Cathrin Buetefisch, Emory University
  Purpose
It is well known that the motor area of one hemisphere of the brain (motor cortex) controls the movement of the opposite of the body. However, it is not clear whether as the movement becomes more complicated, the motor cortex of both hemispheres of the brain are involved. Currently the role of the motor cortex on the same side of the body (referred to as ipsilateral motor cortex) in hand performance remains controversial. The investigators demonstrated previously in healthy subjects that transiently lowering the activity of ipsilateral motor cortex improved the performance of the opposite hand. What is not know are the mechanisms involved in these changes of behavior. Transcranial magnetic stimulation (TMS) is a device that allows the non- invasive stimulation of the brain. When brain is stimulated repetitively at a very low rate and low intensity for about 15 minutes, the stimulated brain area becomes less active. This effect lasts 10 minutes and is called a "transient artificial lesion" as it mimicks the effects of transiently interfering with the function of the stimulated brain area. In the present study the investigators will conduct experiments using repetitive TMS to downregulate the activity of the motor area as in previous experiments and measures its effect on activity of motor cortex of both hemispheres. The investigators will study healthy subjects. It would be important to understand the effects in more detail for the design of treatment strategies in patients after stroke, which will be a topic of future studies.

Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Enhancing Stroke Recovery Through Cortical Stimulation: The Role of the Ipsilateral Motor Cortex in Executing Movements With Increasing Demand on Precision

Further study details as provided by Cathrin Buetefisch, Emory University:

Primary Outcome Measures:
  • Define key parameters that contribute to contralesional M1 reorganization following stroke [ Time Frame: Up to six months post-stroke ]

Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: December 2018
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stroke patients
Healthy Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
30 Stroke patients with 15 in each group based on location of stroke 50 healthy volunteers
Criteria

Inclusion Criteria for Stroke Patients:

  • Age 18-80
  • Single cerebral ischemic infarction one month prior to entering study
  • Affecting only one hemisphere as defined by MRI of the brain
  • At the time of cerebral infarct a motor deficit of hand of Medical Research Council Scale for Muscle Strength (MRC) of < 4- of wrist and finger extension/flexion movement
  • Fugl Meyer score > 27/66 (motor domain, upper extremity)
  • Ability to operate joystick at largest target level
  • No other neurological disorder
  • No intake of Central Nervous System (CNS) active drugs
  • Ability to give informed consent
  • Ability to meet criteria of inclusion experiment
  • No major cognitive impairment

Inclusion Criteria for Healthy Subjects:

  • Age 55-80 years with no neurological or psychiatric diseases
  • Normal neurological examination
  • Normal MRI of the brain
  • Normal neuropsychological testing
  • No intake of CNS active drugs that interfere with data collection
  • No contraindication to TMS
  • Ability to give informed consent
  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): NCT01726218


Locations
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Cathrin Buetefisch
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Cathrin Buetefisch, MD, PhD Emory University
  More Information

Responsible Party: Cathrin Buetefisch, Dr Cathrin Buetefisch, M.D., PhD, Emory University
ClinicalTrials.gov Identifier: NCT01726218     History of Changes
Other Study ID Numbers: IRB00048694
R56NS070879-01 ( U.S. NIH Grant/Contract )
RIMCR56 ( Other Identifier: Other )
First Submitted: March 29, 2012
First Posted: November 14, 2012
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by Cathrin Buetefisch, Emory University:
Stroke
Physical Medicine & Rehabilitation
Neurology
Neurophysiology
Neuroscience
Transcranial Magnetic Stimulation (TMS)

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases