Cerebrovascular AccidentNCT00029718
Interhemispheric Interactions Associated With Performance of Voluntary Movements in Patients With Stroke Motor Disability
An observational study of Cerebrovascular Accident and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use transcranial magnetic stimulation (TMS) to identify interactions between the unaffected and affected side of the brain in stroke patients. Results from previous studies suggest that after a stroke, the motor cortex (part of the brain that controls movement) of the unaffected side of the brain might… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident, Healthy
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2002to 18 Nov 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 and above
- Willingness and ability to perform all tasks as requested
- For stroke patients, history of one, unilateral stroke greater than 6 months prior to enrollment, with initial hand paresis that has recovered to the point of being able to perform the motor task
Who cannot join
- Inability to perform any of the requested tasks
- Folstein mini-mental state exam (Folstein. 1976) score of 23 or less.
- Diagnosis of severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease) or a deteriorated condition due to age
- Diagnosis of alcohol dependence at the time or in the six months prior to participation as made by a community or NIH independent licensed practitioner
- Diagnosis of major depressive disorder at the time or in the six months prior to participation as made by a community or NIH independent licensed practitioner
- Pacemakers, implanted pumps, or stimulators, such as cochlear implants or metal objects inside the eye or skull aside from dental implants
Show all 15Show fewer
- Metal in the cranium except mouth
- Metal fragments from occupational exposure or surgical clips in or near the brain
- Eye, blood vessel, cochlear or eye implants
- History of epilepsy
- Pregnancy
- For healthy volunteers, diagnosis of any neurologic disorder as made by a community or NIH independent licensed practitioner
- For healthy volunteers, active use of any anti-depressant, anti-convulsive, neuroleptic, or psycho-stimulant medications
- For stroke patients: more than one stroke, brainstem or cerebellar stroke, or any history of bilateral paresis
- Lack of capacity to give informed consent
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
This study will use transcranial magnetic stimulation (TMS) to identify interactions between the unaffected and affected side of the brain in stroke patients. Results from previous studies suggest that after a stroke, the motor cortex (part of the brain that controls movement) of the unaffected side of the brain might negatively influence the motor cortex of the affected side. TMS is a procedure that delivers brief electrical currents that stimulate the brain. Studies of a small number of patients have shown that TMS can cause a temporary decrease in activity of the motor cortex.
Healthy normal volunteers and chronic stroke patients may be eligible for this study. Subjects may participate in up to four sessions of reaction time (speed of motor response) testing. They will perform a series of movements with the index and middle fingers of either the left or right hand in response to a signal from a computer monitor. The time it takes to do the tasks will be measured and scored. There will be rest periods during each session.
Read more
TMS will be done each session to examine how the motor cortex affects recovery of function after stroke. For this procedure, an insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. Depending on where the coil is placed, the stimulation may cause a muscle twitch (sometimes strong enough to move the limb), a feeling of movement or tingling in a limb, or twitching of the jaw. During stimulation, the subject may be asked to tense certain muscles slightly or to perform other simple actions. The electrical activity in the muscles activated by the stimulation will be recorded using metal electrodes taped to the skin over the muscles.
Subjects will also be asked to draw a mark on a line on paper to rate their attention and level of fatigue, and how well they think they are executing the tasks.
Participants will also have magnetic resonance imaging (MRI). This procedure uses a strong magnetic field and radio waves to provide detailed images of the brain. During the scanning, the subject wears earplugs to muffle loud thumping sounds that occur with electrical switching of the radio frequency circuits. The subject can communicate with the staff member performing the study at all times through an intercom system.
Read the detailed description
Performance of accurate skilled movements relies on interhemispheric interactions between the two motor cortices. It has been proposed that abnormal interactions could contribute to the motor deficit that results from chronic hemispheric lesions after stroke. The purpose of this protocol is to identify changes in interhemispheric inhibitory interactions associated with performance of a motor task in patients with chronic hemispheric stroke. The overall hypothesis is that the cortical representation of the paretic hand receives abnormally high task-related interhemispheric inhibitory influence originated in the intact motor cortex in stroke patients relative to healthy volunteers. It is important to test this hypothesis, because if proven correct, it could lead to the development of novel neurorehabilitative strategies.
- Conditions
- Cerebrovascular Accident, Healthy
- Keywords
- Chronic Stroke, Transcallosal Inhibition, Motor Cortex, Motor Control, Motor Recovery, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2002 (estimated)
- Study start16 Jan 2002
- Study completion18 Nov 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 Cerebrovascular AccidentStudies 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
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029718
- Sponsor's protocol ID
- 020104
- Other IDs
- 02-N-0104
- Status last verified
- 18 Nov 2011
- First submitted
- 14 Jul 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Boroojerdi B, Diefenbach K, Ferbert A. Transcallosal inhibition in cortical and subcortical cerebral vascular lesions. J Neurol Sci. 1996 Dec;144(1-2):160-70. doi: 10.1016/s0022-510x(96)00222-5.
PubMed 8994119Bridgers SL, Delaney RC. Transcranial magnetic stimulation: an assessment of cognitive and other cerebral effects. Neurology. 1989 Mar;39(3):417-9. doi: 10.1212/wnl.39.3.417.
PubMed 2927652Chen R, Gerloff C, Hallett M, Cohen LG. Involvement of the ipsilateral motor cortex in finger movements of different complexities. Ann Neurol. 1997 Feb;41(2):247-54. doi: 10.1002/ana.410410216.
PubMed 9029074
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
- Interhemispheric Interactions Associated With Performance of Voluntary Movements in Patients With Stroke Motor Disability
- ClinicalTrials.gov ID
- NCT00029718
- Acronym / sponsor ID
- 020104
- Conditions
- Cerebrovascular Accident, Healthy
- Keywords
- Chronic Stroke, Transcallosal Inhibition, Motor Cortex, Motor Control, Motor Recovery, Healthy Volunteer, HV, Normal Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 16 Jan 2002
- Study completion
- 18 Nov 2011
- First posted
- 21 Jan 2002 (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 transcranial magnetic stimulation (TMS) to identify interactions between the unaffected and affected side of the brain in stroke patients. Results from previous studies suggest that after a stroke, the motor cortex (part of the brain that controls movement) of the unaffected side of the brain might negatively influence the motor cortex of the affected side. TMS is a procedure that delivers brief electrical currents that stimulate the brain. Studies of a small number of patients have shown that TMS can cause a temporary decrease in activity of the motor cortex.
Healthy normal volunteers and chronic stroke patients may be eligible for this study. Subjects may participate in up to four sessions of reaction time (speed of motor response) testing. They will perform a series of movements with the index and middle fingers of either the left or right hand in response to a signal from a computer monitor. The time it takes to do the tasks will be measured and scored. There will be rest periods during each session.
TMS will be done each session to examine how the motor cortex affects recovery of function after stroke. For this procedure, an insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. Depending on where the coil is placed, the stimulation may cause a muscle twitch (sometimes strong enough to move the limb), a feeling of movement or tingling in a limb, or twitching of the jaw. During stimulation, the subject may be asked to tense certain muscles slightly or to perform other simple actions. The electrical activity in the muscles activated by the stimulation will be recorded using metal electrodes taped to the skin over the muscles.
Subjects will also be asked to draw a mark on a line on paper to rate their attention and level of fatigue, and how well they think they are executing the tasks.
Participants will also have magnetic resonance imaging (MRI). This procedure uses a strong magnetic field and radio waves to provide detailed images of the brain. During the scanning, the subject wears earplugs to muffle loud thumping sounds that occur with electrical switching of the radio frequency circuits. The subject can communicate with the staff member performing the study at all times through an intercom system.
Detailed description
Performance of accurate skilled movements relies on interhemispheric interactions between the two motor cortices. It has been proposed that abnormal interactions could contribute to the motor deficit that results from chronic hemispheric lesions after stroke. The purpose of this protocol is to identify changes in interhemispheric inhibitory interactions associated with performance of a motor task in patients with chronic hemispheric stroke. The overall hypothesis is that the cortical representation of the paretic hand receives abnormally high task-related interhemispheric inhibitory influence originated in the intact motor cortex in stroke patients relative to healthy volunteers. It is important to test this hypothesis, because if proven correct, it could lead to the development of novel neurorehabilitative strategies.
Study design
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21 and above
- Willingness and ability to perform all tasks as requested
- For stroke patients, history of one, unilateral stroke greater than 6 months prior to enrollment, with initial hand paresis that has recovered to the point of being able to perform the motor task
Key exclusion criteria (15 listed)
- Inability to perform any of the requested tasks
- Folstein mini-mental state exam (Folstein. 1976) score of 23 or less.
- Diagnosis of severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease) or a deteriorated condition due to age
- Diagnosis of alcohol dependence at the time or in the six months prior to participation as made by a community or NIH independent licensed practitioner
- Diagnosis of major depressive disorder at the time or in the six months prior to participation as made by a community or NIH independent licensed practitioner
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 8994119Boroojerdi B, Diefenbach K, Ferbert A. Transcallosal inhibition in cortical and subcortical cerebral vascular lesions. J Neurol Sci. 1996 Dec;144(1-2):160-70. doi: 10.1016/s0022-510x(96)00222-5.
- Background: PubMed 2927652Bridgers SL, Delaney RC. Transcranial magnetic stimulation: an assessment of cognitive and other cerebral effects. Neurology. 1989 Mar;39(3):417-9. doi: 10.1212/wnl.39.3.417.
- Background: PubMed 9029074Chen R, Gerloff C, Hallett M, Cohen LG. Involvement of the ipsilateral motor cortex in finger movements of different complexities. Ann Neurol. 1997 Feb;41(2):247-54. doi: 10.1002/ana.410410216.
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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 Cerebrovascular Accident and Healthy, 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 3 inclusion and 15 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 NCT00029718, 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.