NCT01021033Completed
Screening Protocol for Patients With Stroke
Source: ClinicalTrials.gov · Last updated 6 Mar 2025
Brief summary (registry, in English)
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..
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 62 (actual)
- First submitted
- 25 Nov 2009
- Start date
- 5 Jan 2010
- Primary completion date
- 4 Mar 2025
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Diseases
- Stroke
- NCT number
- NCT01021033
What you commit to
- Study type: Observational
- Participants enrolled: 62
- From 5 Jan 2010 to the primary completion date, 4 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent or ongoing alcohol or drug abuse
- 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)
Other illness
- 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
Other
- 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
- Cognitive deficits defined as a Mini-Mental State Examination (MMSE) score of 20 or less
- Reported current pregnancy (including six weeks postpartum
Criteria the registry did not label
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.