Central Nervous System DiseaseNCT00474292
Influence of Area of Brain Damage on Brain Reorganization After Chronic Stroke
An observational study of Central Nervous System Disease and Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine how the brain rewires itself to make up for the lack of movement many people with stroke experience. It will try to determine if the rewiring differs depending on the location of the stroke and the amount of time since the stroke occurred. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Central Nervous System Disease, Cerebrovascular Accident, Stroke
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2007to 8 Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be aged 18 or above with subacute (at least 3 months post stroke) thromboembolic or hemorrhagic strokes with impaired motor function in at least one of the limbs but capable of performing the required motor tasks. Assessment of the initial functional state will be taken at the initial visit at the NINDS Stroke Neurorehabilitation Clinic. Patients with additional stroke(s) during the length of the protocol will not be excluded from the study if the conditions stated in the Exclusion Criteria are satisfied.
Who cannot join
- Patients with a history of alcohol or drug abuse, poor motivational capacity, or language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
- Patients with medical or technical contraindications to MRI procedures (e.g. metal braces, pacemakers, cochlear devices, surgical clips, and other metal/magnetic implants); claustrophobia; and pregnancy.
- Patients who are unable to comply with the motor testing protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Influence of Lesion Location on Cortical Reorganization After Chronic Stroke
This study will examine how the brain rewires itself to make up for the lack of movement many people with stroke experience. It will try to determine if the rewiring differs depending on the location of the stroke and the amount of time since the stroke occurred. For some stoke patients, weakness may persist, while others recover completely after time. It is not known which parts of the brain are involved in the recovery of different types of stroke and if the type of stroke affects recovery.
People 18 years of age and older who have had subacute thromboembolic or hemorrhagic stroke more than 3 months before enrolling may participate in this study.
Read more
Participants come to the NIH Clinical Center three times every 2 years for up to 10 years. At the first visit, patients have a neurological examination and perform tests of motor abilities such as lifting small objects, turning cards, using a spoon, stacking checkers and lifting cans during a short period of time as rapidly as possible.
At the second visit, subjects have structural magnetic resonance imaging (MRI) scans of the brain. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the scan, the subject lies on a table that can slide in and out of the cylinder, wearing earplugs to muffle loud knocking noises associated with the scanning process. Total scan time is about 30 minutes
At the third visit, subjects perform some simple movement tasks during functional MRI (fMRI) scans. The procedure is the same as with structural MRI, except that subjects are asked to perform simple movement tasks in the scanner. Before the fMRI scans, electrodes are attached to the subject's arms and legs to monitor muscle activity (surface electromyography). Total scan time is about 1.5 hours. Movement tasks might include pinching a force-measuring instrument with the fingers, pressing different keys on a keyboard as fast as possible, inserting pegs into small holes on a board, lifting weights, flipping cards or similar activities.
Read the detailed description
OBJECTIVES:
The purpose of this protocol is to acquire information on the types of cortical reorganization associated with different stroke lesions. This is important for formulating hypotheses on lesion-specific types of cortical plasticity following stroke. Understanding lesion-specific cortical reorganization is essential to advancing our understanding of the mechanism(s) underlying functional reorganization and recovery after stroke.
This protocol will establish a neuroimaging database of brain activations in stroke patients with various lesion sites using task-controlled functional and high-resolution structural magnetic resonance imaging (MRI) methods and detailed monitoring of task performance in the scanner (electromyography [EMG] and motor kinematics). Specifically, we propose to acquire the following from each new patient in the clinic who has had a stroke at least 3 months prior to their visit:
- A high-resolution T1-weighted structural scan and T2-weighted MRI; used to characterize lesion location and to quantify tissue loss.
- A functional magnetic resonance imaging (fMRI) scan with standardized motor tasks.
Both will be repeated every two years, for up to 10 years to provide preliminary information on the consistency of plastic changes over time in the chronic stage. This information will be used to generate future hypotheses and power analysis on lesion-specific forms of cortical reorganization.
STUDY POPULATION:
One hundred and twenty five stroke patients aged 18 or above with motor function impairment.
DESIGN:
All stroke patients under this protocol will complete the following evaluations during their initial visit: clinical interview and neurological exam, the National Institutes of Health Stroke Scale (NIH Stroke Scale), the Medical Research Council (MRC), and Jebsen-Taylor scores.
Following the initial screening, subjects will be asked to participate in up to two MRI sessions every two years. Session 1 includes anatomical MRI scans (T1- and T2-weighted); Session 2 involves BOLD functional MRI scans.
OUTCOME MEASURES:
Outcome measures will include lesion loci and size, gray matter loss (volume size), white matter loss (volume size), total white matter volume, total gray matter volume, patterns of fMRI BOLD activation within and across sessions, the NIH Stroke scale, the MRC, and Jebsen-Taylor test scores.
- Keywords
- Stroke, Rehabilitation, Plasticity, fMRI, Reorganization
- Medical subject headings
- Central Nervous System Diseases, Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study start14 May 2007
- Study completion8 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474292
- Sponsor's protocol ID
- 070154
- Other IDs
- 07-N-0154
- Status last verified
- 8 Apr 2011
- First submitted
- 15 May 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Calautti C, Leroy F, Guincestre JY, Baron JC. Dynamics of motor network overactivation after striatocapsular stroke: a longitudinal PET study using a fixed-performance paradigm. Stroke. 2001 Nov;32(11):2534-42. doi: 10.1161/hs1101.097401.
PubMed 11692013Calautti C, Baron JC. Functional neuroimaging studies of motor recovery after stroke in adults: a review. Stroke. 2003 Jun;34(6):1553-66. doi: 10.1161/01.STR.0000071761.36075.A6. Epub 2003 May 8.
PubMed 12738893Duyn JH, van Gelderen P, Talagala L, Koretsky A, de Zwart JA. Technological advances in MRI measurement of brain perfusion. J Magn Reson Imaging. 2005 Dec;22(6):751-3. doi: 10.1002/jmri.20450.
PubMed 16267852
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lesion Location on Cortical Reorganization After Chronic Stroke
- ClinicalTrials.gov ID
- NCT00474292
- Acronym / sponsor ID
- 070154
- Keywords
- Stroke, Rehabilitation, Plasticity, fMRI, Reorganization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 14 May 2007
- Study completion
- 8 Apr 2011
- First posted
- 16 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine how the brain rewires itself to make up for the lack of movement many people with stroke experience. It will try to determine if the rewiring differs depending on the location of the stroke and the amount of time since the stroke occurred. For some stoke patients, weakness may persist, while others recover completely after time. It is not known which parts of the brain are involved in the recovery of different types of stroke and if the type of stroke affects recovery.
People 18 years of age and older who have had subacute thromboembolic or hemorrhagic stroke more than 3 months before enrolling may participate in this study.
Participants come to the NIH Clinical Center three times every 2 years for up to 10 years. At the first visit, patients have a neurological examination and perform tests of motor abilities such as lifting small objects, turning cards, using a spoon, stacking checkers and lifting cans during a short period of time as rapidly as possible.
At the second visit, subjects have structural magnetic resonance imaging (MRI) scans of the brain. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the scan, the subject lies on a table that can slide in and out of the cylinder, wearing earplugs to muffle loud knocking noises associated with the scanning process. Total scan time is about 30 minutes
At the third visit, subjects perform some simple movement tasks during functional MRI (fMRI) scans. The procedure is the same as with structural MRI, except that subjects are asked to perform simple movement tasks in the scanner. Before the fMRI scans, electrodes are attached to the subject's arms and legs to monitor muscle activity (surface electromyography). Total scan time is about 1.5 hours. Movement tasks might include pinching a force-measuring instrument with the fingers, pressing different keys on a keyboard as fast as possible, inserting pegs into small holes on a board, lifting weights, flipping cards or similar activities.
Detailed description
OBJECTIVES:
The purpose of this protocol is to acquire information on the types of cortical reorganization associated with different stroke lesions. This is important for formulating hypotheses on lesion-specific types of cortical plasticity following stroke. Understanding lesion-specific cortical reorganization is essential to advancing our understanding of the mechanism(s) underlying functional reorganization and recovery after stroke.
This protocol will establish a neuroimaging database of brain activations in stroke patients with various lesion sites using task-controlled functional and high-resolution structural magnetic resonance imaging (MRI) methods and detailed monitoring of task performance in the scanner (electromyography [EMG] and motor kinematics). Specifically, we propose to acquire the following from each new patient in the clinic who has had a stroke at least 3 months prior to their visit:
- A high-resolution T1-weighted structural scan and T2-weighted MRI; used to characterize lesion location and to quantify tissue loss.
- A functional magnetic resonance imaging (fMRI) scan with standardized motor tasks.
Both will be repeated every two years, for up to 10 years to provide preliminary information on the consistency of plastic changes over time in the chronic stage. This information will be used to generate future hypotheses and power analysis on lesion-specific forms of cortical reorganization.
STUDY POPULATION:
One hundred and twenty five stroke patients aged 18 or above with motor function impairment.
DESIGN:
All stroke patients under this protocol will complete the following evaluations during their initial visit: clinical interview and neurological exam, the National Institutes of Health Stroke Scale (NIH Stroke Scale), the Medical Research Council (MRC), and Jebsen-Taylor scores.
Following the initial screening, subjects will be asked to participate in up to two MRI sessions every two years. Session 1 includes anatomical MRI scans (T1- and T2-weighted); Session 2 involves BOLD functional MRI scans.
OUTCOME MEASURES:
Outcome measures will include lesion loci and size, gray matter loss (volume size), white matter loss (volume size), total white matter volume, total gray matter volume, patterns of fMRI BOLD activation within and across sessions, the NIH Stroke scale, the MRC, and Jebsen-Taylor test scores.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be aged 18 or above with subacute (at least 3 months post stroke) thromboembolic or hemorrhagic strokes with impaired motor function in at least one of the limbs but capable of performing the required motor tasks. Assessment of the initial functional state will be taken at the initial visit at the NINDS Stroke Neurorehabilitation Clinic. Patients with additional stroke(s) during the length of the protocol will not be excluded from the study if the conditions stated in the Exclusion Criteria are satisfied.
Key exclusion criteria (3 listed)
- Patients with a history of alcohol or drug abuse, poor motivational capacity, or language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
- Patients with medical or technical contraindications to MRI procedures (e.g. metal braces, pacemakers, cochlear devices, surgical clips, and other metal/magnetic implants); claustrophobia; and pregnancy.
- Patients who are unable to comply with the motor testing protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11692013Calautti C, Leroy F, Guincestre JY, Baron JC. Dynamics of motor network overactivation after striatocapsular stroke: a longitudinal PET study using a fixed-performance paradigm. Stroke. 2001 Nov;32(11):2534-42. doi: 10.1161/hs1101.097401.
- Background: PubMed 12738893Calautti C, Baron JC. Functional neuroimaging studies of motor recovery after stroke in adults: a review. Stroke. 2003 Jun;34(6):1553-66. doi: 10.1161/01.STR.0000071761.36075.A6. Epub 2003 May 8.
- Background: PubMed 16267852Duyn JH, van Gelderen P, Talagala L, Koretsky A, de Zwart JA. Technological advances in MRI measurement of brain perfusion. J Magn Reson Imaging. 2005 Dec;22(6):751-3. doi: 10.1002/jmri.20450.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Disease and Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00474292, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.