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Protocol Details

Screening Protocol for Patients with Stroke

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-N-0012

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 90

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Ischemia;
Hemorrhage;
Rehabilitation

Recruitment Keyword(s)

None

Condition(s)

Chronic Stroke

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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..

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Eligibility

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)


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Leonardo G. Cohen, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D54
10 CENTER DR
BETHESDA MD 20814
(301) 496-9782
cohenl1@mail.nih.gov

Margaret K. Hayward, C.R.N.P.
National Institute of Neurological Disorders and Stroke (NINDS)
NIHBC 10 - CLINICAL CENTER BG RM 7D51B
10 CENTER DR
BETHESDA MD 20892
(301) 451-1335
mimi.hayward@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01021033

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