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| ID | Type | Description | Link |
|---|---|---|---|
| 10-N-0012 |
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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:
Study Description:
This study is intended to identify stroke patients for the studies investigating parameters of peripheral and central nervous system stimulation, possible combination of behavioral parameters, and physical therapy to enhance motor recovery
Objectives:
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 after brain lesions like stroke.
Endpoints:
The outcome measure is the number of subjects who are eligible to subsequently enroll in HCPS studies.
Study Population:
Up to Twelve hundred adult patients with history of stroke that occurred at least three months prior to participation and meeting the eligibility criteria, below will be enrolled.
Description of Sites/Facilities Enrolling Participants:
This protocol utilizes the NIH Clinical Center Outpatient Clinic
Study Duration:
15 years
Participant Duration:
One main screening visit that may be remote, in-person or both lasting approximately 4-5 hours with periodic optional return visits as needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic stroke patients | Chronic stroke patients |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this protocol is to enable phenotypic characterizations of stroke patients who participate in this and other NIH protocols addressing chronic stroke. | Description of clinical characteristics of stroke patients, and collection of CDE. Additionally, there will be provision of information (such as CDEs) to other HCPS IRB-approved protocols. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objective of this protocol is to determine how phenotyping interacts with eligibility for HCPS or other NINDS protocols. | Determine eligibility for inclusion in other NIH protocols. | 3 years |
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This study will enroll:
EXCLUSION CRITERIA:
Subjects with the following will be excluded:
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Adult patients with stroke that occurred at least 3 months prior to participation and meeting the eligibility criteria listed in the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Leonardo G Cohen, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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We do not currently have a plan to share IPD.
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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