Screening Protocol for Patients With Stroke

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.

• 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)