Screening Protocol for Patients With Stroke
Tracking Information | |||||
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First Received Date ICMJE | November 25, 2009 | ||||
Last Updated Date | August 24, 2012 | ||||
Start Date ICMJE | November 2009 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT01021033 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Screening Protocol for Patients With Stroke | ||||
Official Title ICMJE | Screening Protocol for Patients With Stroke | ||||
Brief Summary | Background:
Objectives: - To perform a screening evaluation of patients referred with stroke to determine their eligibility for current and future protocols studying the effects of stroke on the nervous system and motor function. Eligibility: - Individuals who have experienced a single stroke on only one side of the brain that occurred at least 3 months prior to participation in the screening study. Individuals must have some residual hand motor function. Design:
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Detailed Description | Objective: The purpose of this protocol is to perform a screening evaluation of patients referred with stroke to determine their eligibility for current and future protocols aimed at understanding the mechanisms underlying plastic changes in the human central nervous system, and how the non-invasive stimulation of the motor cortex could improve motor function in patients with chronic stroke. Study population: Twelve hundred adult patients with monohemispheric single stroke, that occurred at least 3 months prior to participation in this screening study, and with some residual hand motor function will be enrolled. Design: This is a screening protocol to determine eligibility for other branch protocols. Outcome measures: The outcome measure is the number of subjects who subsequently enroll in HCPS studies. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | |||||
Biospecimen | |||||
Sampling Method | |||||
Study Population | |||||
Condition ICMJE | Stroke | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | |||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Suspended | ||||
Enrollment ICMJE | 41 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE |
This study will enroll:
EXCLUSION CRITERIA: Subjects with the following will be excluded:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01021033 | ||||
Other Study ID Numbers ICMJE | 100012, 10-N-0012 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | October 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |