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Screening Protocol for Patients With Stroke

Screening Protocol for Patients With Stroke

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01021033
Enrollment
62
Registered
2009-11-26
Start date
2010-01-05
Completion date
2025-03-04
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke

Keywords

Ischemia, Hemorrhage, Rehabilitation

Brief summary

Background: * 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. 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: * 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..

Detailed description

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.

Interventions

None listed

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
Lead SponsorNIH

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* INCLUSION CRITERIA: This study will enroll: * Patients who have had a stroke at least 3 months prior to enrollment; * Patients between the ages of 18 and 90 * Patients who are willing and able to give their own consent

Exclusion criteria

Subjects with the following will be excluded: * HCPS-affiliated NIH staff * Those with known large cerebellar or brainstem lesions as determined by the screening clincian * Recent or ongoing alcohol or drug abuse * Reported severe or progressive neurological disorder other than stroke as determined by the screening clinician. * Have uncontrolled heart, lung, kidney, gastrointestinal, metabolic, or endocrine disorders, as determined by the screening clinician * Cognitive deficits defined as a Mini-Mental State Examination (MMSE) score of 20 or less * Reported current pregnancy (including six weeks postpartum * MRI contraindications as per NMR Center MRI Safety Screening Questionnaire are an exclusion for MRI participation; they are also an exclusion for the study if the patient is not able to provide prior imaging records indicative of stroke history (as determined by screening clinician)

Design outcomes

Primary

MeasureTime frameDescription
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.3 yearsDescription 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.

Secondary

MeasureTime frameDescription
The secondary objective of this protocol is to determine how phenotyping interacts with eligibility for HCPS or other NINDS protocols.3 yearsDetermine eligibility for inclusion in other NIH protocols.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026