Screening Protocol for Patients With Stroke
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01021033|
Recruitment Status : Recruiting
First Posted : November 26, 2009
Last Update Posted : June 19, 2018
- Stroke, also known as acute cerebrovascular attack, is the leading cause of long-term disability worldwide. Stroke survivors are often left with permanent physical and mental disabilities.
- Many stroke patients receive different therapies in an attempt to improve their independence and quality of life. However, current strategies are focused on the acute stage after stroke and are of limited influence in improving stroke outcome. One of the main problems of patients who have suffered a stroke is the difficulty in using the hand on the opposite side of the affected hemisphere of the brain; to date, researchers have no successful means to improve the hand function in chronic stages of stroke.
- Researchers are interested in developing a pool of individuals for further research into hand and motor function after a stroke.
- 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.
- 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.
- Participants in this study will be recruited from patient referrals.
- Eligible participants will undergo a 4- to 5-hour screening with a medical history, physical and neurological examination, stroke evaluation, and an anatomical magnetic resonance imaging (MRI) of the brain. The screening visit may be done over the course of more than one day, if needed for patient convenience or test availability.
- In addition to the initial outpatient visit, subjects may remain enrolled in this study for up to 15 years and may be contacted to see if they qualify for new branch studies. Subjects may be re-examined up to once per year while they remain in this protocol to confirm ongoing eligibility. The re-examination visits will involve a neurologic evaluation and possible repeat MRI.
- No clinical care will be provided under this protocol..
|Condition or disease|
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.
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.
This is a screening protocol to determine eligibility for other branch protocols.
The outcome measure is the number of subjects who subsequently enroll in HCPS studies.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Screening Protocol for Patients With Stroke|
|Study Start Date :||November 2, 2009|
- This is a screening protocol. The primary outcome measure is the number of subjects who subsequently enroll in HCPS studies. [ Time Frame: Ongoing ]
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): NCT01021033
|Contact: Margaret K Hayward, C.R.N.P.||(301) firstname.lastname@example.org|
|Contact: Leonardo G Cohen, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Leonardo G Cohen, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|