- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01726218
Role of Ipsilateral Motor Cortex in Executing Movements With Increasing Demand on Precision (RIMC)
October 12, 2018 updated by: Cathrin Buetefisch
Enhancing Stroke Recovery Through Cortical Stimulation: The Role of the Ipsilateral Motor Cortex in Executing Movements With Increasing Demand on Precision
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
30 Stroke patients with 15 in each group based on location of stroke 50 healthy volunteers
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Stroke patients
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Healthy Control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Define key parameters that contribute to contralesional M1 reorganization following stroke
Time Frame: Up to six months post-stroke
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Up to six months post-stroke
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2011
Primary Completion (Actual)
March 26, 2015
Study Completion (Actual)
March 26, 2015
Study Registration Dates
First Submitted
March 29, 2012
First Submitted That Met QC Criteria
November 9, 2012
First Posted (Estimate)
November 14, 2012
Study Record Updates
Last Update Posted (Actual)
October 15, 2018
Last Update Submitted That Met QC Criteria
October 12, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00048694
- R56NS070879-01 (U.S. NIH Grant/Contract)
- RIMCR56 (Other Identifier: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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