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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Emory University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Cathrin Buetefisch, Emory University
ClinicalTrials.gov Identifier:
NCT01726218
First received: March 29, 2012
Last updated: April 14, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Define key parameters that contribute to contralesional M1 reorganization following stroke [ Time Frame: Up to six months post-stroke ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stroke patients
Healthy Control

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT01726218

Contacts
Contact: Farrah 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 Rink, MHSc    678-369-3152    frink@emory.edu   
Principal Investigator: Cathrin Buetefisch, MD, PhD         
Sponsors and Collaborators
Cathrin Buetefisch
Investigators
Principal Investigator: Cathrin Buetefisch, MD, PhD Emory University
  More Information

No publications provided

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, RIMCR56
Study First Received: March 29, 2012
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 21, 2014