Screening Protocol for Patients With Stroke
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/15/2019 |
| Start Date: | November 2, 2009 |
| Contact: | Margaret K Hayward, C.R.N.P. |
| Email: | mimi.hayward@nih.gov |
| Phone: | (301) 451-1335 |
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..
- 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..
Objective:
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, and how the
non-invasive stimulation of the motor cortex could improve motor function in patients with
chronic stroke.
Study population:
Twelve hundred adult patients with monohemispheric single stroke, that occurred at least 3
months prior to participation in this screening study, and with some residual hand motor
function will be enrolled.
Design:
This is a screening protocol to determine eligibility for other branch protocols.
Outcome measures:
The outcome measure is the number of subjects who subsequently enroll in HCPS studies.
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, and how the
non-invasive stimulation of the motor cortex could improve motor function in patients with
chronic stroke.
Study population:
Twelve hundred adult patients with monohemispheric single stroke, that occurred at least 3
months prior to participation in this screening study, and with some residual hand motor
function will be enrolled.
Design:
This is a screening protocol to determine eligibility for other branch protocols.
Outcome measures:
The outcome measure is the number of subjects who subsequently enroll in HCPS studies.
- INCLUSION CRITERIA:
This study will enroll:
- Patients with stroke documented by medical record report,CT or Magnetic resonance
imaging (MRI) 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
- Patients with monohemispheric, single or multiple strokes which affected the hand
EXCLUSION CRITERIA:
Subjects with the following will be excluded:
- Large, cerebellar, or brainstem lesions
- Recent or ongoing alcohol or drug abuse
- Severe or progressive neurological disorder other than stroke as determined by the
screening clinician.
- Uncontrolled heart, lung, kidney, gastrointestinal, metabolic, or endocrine disorders
as determined by the screening clinician
- MRI contraindications as per NMR Center MRI Safety Screening Questionnaire.
- Cognitive deficits defined as a mini-mental state exam score of 20 or less
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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