HealthyNCT00006424
Study of Brain Changes Shaped by Experience
An observational study of Healthy and Neurologic Manifestations, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use magnetic resonance imaging (MRI) scans to explore how the brain changes (reorganizes itself) in response to learning and to brain lesions in healthy people and people with various physical disabilities. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Neurologic Manifestations
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Jan 2002
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Patients must be able to give informed consent.
Patients recruited would come from those referred to the Human Cortical Physiology Section who would have distinct neurological syndromes from well-defined peripheral and central nervous system lesions including stroke, hemipherectomy, and amputation.
Healthy adults without history of neurological disease.
Pregnant women will be excluded.
Subjects with metal in the cranium except mouth will be excluded.
Subjects with dental braces will be excluded.
Subjects with metal fragments from occupational exposure or surgical clips in or near the brain will be excluded.
Subjects with eye, blood vessel, cochlear or eye implants will be excluded.
Subjects with increased intracranial pressure as evaluated by clinical means will be excluded.
Subjects with cardiac or neural pacemakers will be excluded.
Subjects with intracardiac lines and implanted medication pumps will be excluded.
ADDITIONAL INCLUSION CRITERIA WHEN AMPHETAMINE IS USED:
Subjects with large hemorrhagic or brain stem stroke will be excluded.
Subjects with multiple cerebral lesions with residual deficits will be excluded.
Subjects with history of head injury with loss of consciousness will be excluded.
Subjects with history of severe alcohol or drug abuse will be excluded.
Subjects with history of psychiatric illness will be excluded.
Subjects with unstable cardiac dysrhythmia or unresponsive arterial hypertension (greater than 160/100 mmHg) will be excluded.
Subjects with history of hyperthyroidism will be excluded.
Subjects receiving alpha-adrenergic antagonists or agonist, major/minor tranquilizers, clonidine, prazosin, phenytoin, benzodiazepines, scopolamine, haloperidol, other neuroleptics, barbiturates will be excluded.
Subjects with glaucoma, history of hypersensitivity or idiosyncrasy to sympatomimetic drugs will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: fMRI and Spectroscopy Studies of Cortical Plasticity at 1.5 and 3 Tesla
This study will use magnetic resonance imaging (MRI) scans to explore how the brain changes (reorganizes itself) in response to learning and to brain lesions in healthy people and people with various physical disabilities.
Normal volunteers and patients with disabilities including blindness, limb amputation, hemispherectomy (removal of a cerebral hemisphere), and stroke may be eligible for this study. Candidates will be screened with medical and neurological examinations.
Read more
Participants will have MRI scans while they lie still or perform certain movements, as instructed. MRI uses a strong magnetic field and radio waves instead of X-rays to show structural and chemical changes in tissues. During the scan, the subject lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member through an intercom system at all times during the procedure. All participants will first have a scan to show brain structure, which will take about 30 minutes. A second scan will measure blood flow or biochemical concentration and will take from 1 to 2 1/2 hours.
Depending on their disability, patients will participate in one of the following tests:
- Blindness-This will study the ability of blind people to process tactile information.
- Stroke- This will study mechanisms underlying recovery of motor function after stroke. The patient will perform voluntary movements or remain still during the scan.
- Amputation- This will study mechanisms underlying the ability of the brain to reorganize after amputation. The patient will move different parts of the body or remain still during the scan.
- Hemispherectomy- This will study mechanisms underlying the ability of one side of the brain to control movements of both arms. The patient will make different kinds of movements during the scan.
Normal volunteers will participate in one of the following tests:
- Use-dependent plasticity- This will evaluate the effectiveness of amphetamine and placebo in demonstrating brain flexibility. The volunteer will take an amphetamine or placebo (inactive pill) before the scan and then perform a specific exercise using the thumb.
- Motor fatigue- This will study the mechanisms that underlie fatigue, which affect many patients with neurological conditions. The volunteer will contract muscles in the forearm and hand for several minutes until he or she feels fatigue.
- Light deprivation- This will evaluate changes in the brain that occur after light deprivation. The volunteer will remain at rest in the scanner for up to 150 minutes.
- Somatosensory stimulation-This will examine whether stimulation of the wrist can cause changes in hand representation in the part of the brain that controls movement. The volunteer will make hand movements at different times during the test. In addition, mild electric shocks will be delivered to the wrist for up to 2 hours. Although the shock intensity is regulated to avoid pain, there may be some discomfort.
Read the detailed description
The purpose of this protocol is to investigate plastic changes in human cerebral cortex in health and disease. The overall hypothesis is that it is possible to identify neuroimaging patterns reflecting reorganization in the human cerebral cortex using fMRI and that it is possible to obtain information on the mechanisms underlying some of these plastic changes by using magnetic resonance spectroscopy (MRS) of GABA. This information is potentially important for the understanding of mechanisms of cortical reorganization operating in humans. Patients and normal volunteers will be scanned at rest and during performance of different tasks. These studies should provide new information on mechanisms of human plasticity. The MRI techniques used for that purpose are functional MRI (fMRI), MR spectroscopy (MRS), and conventional MRI with magnets between 1.5 and 4 tesla.
- Conditions
- Healthy, Neurologic Manifestations
- Keywords
- Plasticity, Motor, Stroke, Amphetamine, fMRI, Cortical Reorganization, Spectroscopy
- Medical subject headings
- Neurologic Manifestations, Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2000 (estimated)
- Study startOct 2000
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Enrolment
- 153 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006424
- Sponsor's protocol ID
- 010012
- Other IDs
- 01-N-0012
- Status last verified
- Jan 2002
- First submitted
- 28 Oct 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Merzenich MM, Kaas JH, Wall JT, Sur M, Nelson RJ, Felleman DJ. Progression of change following median nerve section in the cortical representation of the hand in areas 3b and 1 in adult owl and squirrel monkeys. Neuroscience. 1983 Nov;10(3):639-65. doi: 10.1016/0306-4522(83)90208-7.
PubMed 6646426
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI and Spectroscopy Studies of Cortical Plasticity at 1.5 and 3 Tesla
- ClinicalTrials.gov ID
- NCT00006424
- Acronym / sponsor ID
- 010012
- Conditions
- Healthy, Neurologic Manifestations
- Keywords
- Plasticity, Motor, Stroke, Amphetamine, fMRI, Cortical Reorganization, Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 2000
- Study completion
- Jan 2002
- First posted
- 30 Oct 2000 (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 use magnetic resonance imaging (MRI) scans to explore how the brain changes (reorganizes itself) in response to learning and to brain lesions in healthy people and people with various physical disabilities.
Normal volunteers and patients with disabilities including blindness, limb amputation, hemispherectomy (removal of a cerebral hemisphere), and stroke may be eligible for this study. Candidates will be screened with medical and neurological examinations.
Participants will have MRI scans while they lie still or perform certain movements, as instructed. MRI uses a strong magnetic field and radio waves instead of X-rays to show structural and chemical changes in tissues. During the scan, the subject lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member through an intercom system at all times during the procedure. All participants will first have a scan to show brain structure, which will take about 30 minutes. A second scan will measure blood flow or biochemical concentration and will take from 1 to 2 1/2 hours.
Depending on their disability, patients will participate in one of the following tests:
- Blindness-This will study the ability of blind people to process tactile information.
- Stroke- This will study mechanisms underlying recovery of motor function after stroke. The patient will perform voluntary movements or remain still during the scan.
- Amputation- This will study mechanisms underlying the ability of the brain to reorganize after amputation. The patient will move different parts of the body or remain still during the scan.
- Hemispherectomy- This will study mechanisms underlying the ability of one side of the brain to control movements of both arms. The patient will make different kinds of movements during the scan.
Normal volunteers will participate in one of the following tests:
- Use-dependent plasticity- This will evaluate the effectiveness of amphetamine and placebo in demonstrating brain flexibility. The volunteer will take an amphetamine or placebo (inactive pill) before the scan and then perform a specific exercise using the thumb.
- Motor fatigue- This will study the mechanisms that underlie fatigue, which affect many patients with neurological conditions. The volunteer will contract muscles in the forearm and hand for several minutes until he or she feels fatigue.
- Light deprivation- This will evaluate changes in the brain that occur after light deprivation. The volunteer will remain at rest in the scanner for up to 150 minutes.
- Somatosensory stimulation-This will examine whether stimulation of the wrist can cause changes in hand representation in the part of the brain that controls movement. The volunteer will make hand movements at different times during the test. In addition, mild electric shocks will be delivered to the wrist for up to 2 hours. Although the shock intensity is regulated to avoid pain, there may be some discomfort.
Detailed description
The purpose of this protocol is to investigate plastic changes in human cerebral cortex in health and disease. The overall hypothesis is that it is possible to identify neuroimaging patterns reflecting reorganization in the human cerebral cortex using fMRI and that it is possible to obtain information on the mechanisms underlying some of these plastic changes by using magnetic resonance spectroscopy (MRS) of GABA. This information is potentially important for the understanding of mechanisms of cortical reorganization operating in humans. Patients and normal volunteers will be scanned at rest and during performance of different tasks. These studies should provide new information on mechanisms of human plasticity. The MRI techniques used for that purpose are functional MRI (fMRI), MR spectroscopy (MRS), and conventional MRI with magnets between 1.5 and 4 tesla.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 4 Mar 2008.
- Background: PubMed 6646426Merzenich MM, Kaas JH, Wall JT, Sur M, Nelson RJ, Felleman DJ. Progression of change following median nerve section in the cortical representation of the hand in areas 3b and 1 in adult owl and squirrel monkeys. Neuroscience. 1983 Nov;10(3):639-65. doi: 10.1016/0306-4522(83)90208-7.
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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 Healthy and Neurologic Manifestations, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 NCT00006424, which also lists 1 linked publication.
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 4 Mar 2008.