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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01726218
Other study ID # IRB00048694
Secondary ID R56NS070879-01RI
Status Completed
Phase
First received
Last updated
Start date May 2011
Est. completion date March 26, 2015

Study information

Verified date October 2018
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 26, 2015
Est. primary completion date March 26, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Emory University School of Medicine Atlanta Georgia

Sponsors (3)

Lead Sponsor Collaborator
Cathrin Buetefisch National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Define key parameters that contribute to contralesional M1 reorganization following stroke Up to six months post-stroke
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