Screening Protocol for Patients With Stroke

NCT01021033 | Completed

• 2 other identifiers: 10001210-N-0012
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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..

Conditions

Chronic Stroke

Keywords

Ischemia; Hemorrhage; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The secondary objective of this protocol is to determine how phenotyping interacts with eligibility for HCPS or other NINDS protocols.

  3 years

Study Arms (1)

Chronic stroke patients

Chronic stroke patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with stroke that occurred at least 3 months prior to participation and meeting the eligibility criteria listed in the protocol.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Ischemia; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leonardo G Cohen, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 26, 2009
• Study Start: January 5, 2010
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)