EpilepsyNCT00036595
Functional Coupling of Cortico-Cortical and Cortico-Muscular Connections During Motor Movements: An Electrocorticographic Study of Ipsilateral Motor Control
An observational study of Epilepsy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study examines the relationship between a cerebral hemisphere and control of muscles on the same side of the body (ipsilateral control). One good way to study this relationship is to record electroencephalogram (EEG) activity directly from the cortical surface. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to May 2006
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PATIENTS UNDERGOING SUBDURAL IMPLANTATION:
- Epileptic patients who are undergoing invasive recording with implanted subdural electrodes that cover the sensorimotor cortices.
- Therefore, we will recruit only those patients with medically intractable epilepsy who are candidates for surgical treatment, and in whom invasive monitoring was deemed necessary for the purpose of precise localization of epileptogenic zones.
Who cannot join
- EPILEPTIC PATIENTS:
- Patients whose electrode implantation does not cover the sensorimotor cortices.
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: Functional Coupling Of Cortico-Cortical and Cortico-Muscular Connections During Motor Movements: An Electrocorticographic Study of Ipsilateral Motor Control
This study examines the relationship between a cerebral hemisphere and control of muscles on the same side of the body (ipsilateral control). One good way to study this relationship is to record electroencephalogram (EEG) activity directly from the cortical surface. Because patients with epilepsy who are surgical candidates are already undergoing monitoring with subdural and/or depth electrodes, they present an opportunity to study ipsilateral control. Studying the electrocorticographic (ECoG) activity associated with simple voluntary movement in such patients would not disturb ongoing monitoring of nearby areas of the brain, nor would it endanger the patients.
Ten patients, who may be children or adults, will be recruited for this study. Brain activity will be measured while they move the corner of their mouth and their fingers, wrists, arms, and feet. The baseline measurements will be done with scalp electrodes. Once subdural electrodes have been placed, a second set of measurements will be done. Surface EMG electrodes will be placed on the muscles whose movements are being tested. The tests will be done on no more than 3 separate days, in sessions no longer than 2 hours, for each patient.
Read the detailed description
A corticomuscular functional relationship has been well addressed in the literature in terms of the control exerted by the primary motor region of the cerebral cortex over the contralateral extremities (Mima and Hallet 1999). However, the relationship between a cerebral hemisphere and ipsilateral motor control is not well understood. We hypothesize that a cortical motor control region ipsilateral to the extremities is located in Brodmann's area 6. There are several methods that can be used to study this relationship in terms of cortical region involved: coherence, correlation, and event-related desynchronization and synchronization. Cortical EEG activity associated with contralateral limb activity or stimulation usually is larger than that associated with ipsilateral limb activity. Furthermore, activity over the scalp that is ipsilateral to motor activity is very small and difficult to identify as compared with that occurring contralaterally. Recording responses directly from the cortical surface would improve the ability to identify this activity. An occasion that would allow us such an opportunity would be invasive monitoring in patients with epilepsy.
Epileptic patients who are surgical candidates, but require more precise localization of epileptogenic zones, typically undergo long-term video-EEG monitoring with subdural and/or depth electrodes. Some patients may have seizure onsets close to the sensory-motor area of the brain and require functional mapping in terms of motor function. We would like the opportunity to study electrocorticographic (ECoG) activity associated with simple movements in these patients who are undergoing invasive monitoring.
This study will not disturb ongoing monitoring, nor endanger the patient since no activation or stimulation is involved.
- Conditions
- Epilepsy
- Keywords
- Subdural, Epilepsy, Motor Function, Desynchronization, Coherence, Motor Control
- Medical subject headings
- Epilepsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2002 (estimated)
- Study startMay 2002
- Study completionMay 2006
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 EpilepsyStudies 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
- 20 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036595
- Sponsor's protocol ID
- 020199
- Other IDs
- 02-N-0199
- Status last verified
- May 2006
- First submitted
- 10 May 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Andrew C, Pfurtscheller G. Event-related coherence as a tool for studying dynamic interaction of brain regions. Electroencephalogr Clin Neurophysiol. 1996 Feb;98(2):144-8. doi: 10.1016/0013-4694(95)00228-6.
PubMed 8598174Conway BA, Halliday DM, Farmer SF, Shahani U, Maas P, Weir AI, Rosenberg JR. Synchronization between motor cortex and spinal motoneuronal pool during the performance of a maintained motor task in man. J Physiol. 1995 Dec 15;489 ( Pt 3)(Pt 3):917-24. doi: 10.1113/jphysiol.1995.sp021104.
PubMed 8788955Bartolomei F, Wendling F, Vignal JP, Kochen S, Bellanger JJ, Badier JM, Le Bouquin-Jeannes R, Chauvel P. Seizures of temporal lobe epilepsy: identification of subtypes by coherence analysis using stereo-electro-encephalography. Clin Neurophysiol. 1999 Oct;110(10):1741-54. doi: 10.1016/s1388-2457(99)00107-8.
PubMed 10574289
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
- Functional Coupling Of Cortico-Cortical and Cortico-Muscular Connections During Motor Movements: An Electrocorticographic Study of Ipsilateral Motor Control
- ClinicalTrials.gov ID
- NCT00036595
- Acronym / sponsor ID
- 020199
- Conditions
- Epilepsy
- Keywords
- Subdural, Epilepsy, Motor Function, Desynchronization, Coherence, Motor Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- May 2002
- Study completion
- May 2006
- First posted
- 13 May 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 examines the relationship between a cerebral hemisphere and control of muscles on the same side of the body (ipsilateral control). One good way to study this relationship is to record electroencephalogram (EEG) activity directly from the cortical surface. Because patients with epilepsy who are surgical candidates are already undergoing monitoring with subdural and/or depth electrodes, they present an opportunity to study ipsilateral control. Studying the electrocorticographic (ECoG) activity associated with simple voluntary movement in such patients would not disturb ongoing monitoring of nearby areas of the brain, nor would it endanger the patients.
Ten patients, who may be children or adults, will be recruited for this study. Brain activity will be measured while they move the corner of their mouth and their fingers, wrists, arms, and feet. The baseline measurements will be done with scalp electrodes. Once subdural electrodes have been placed, a second set of measurements will be done. Surface EMG electrodes will be placed on the muscles whose movements are being tested. The tests will be done on no more than 3 separate days, in sessions no longer than 2 hours, for each patient.
Detailed description
A corticomuscular functional relationship has been well addressed in the literature in terms of the control exerted by the primary motor region of the cerebral cortex over the contralateral extremities (Mima and Hallet 1999). However, the relationship between a cerebral hemisphere and ipsilateral motor control is not well understood. We hypothesize that a cortical motor control region ipsilateral to the extremities is located in Brodmann's area 6. There are several methods that can be used to study this relationship in terms of cortical region involved: coherence, correlation, and event-related desynchronization and synchronization. Cortical EEG activity associated with contralateral limb activity or stimulation usually is larger than that associated with ipsilateral limb activity. Furthermore, activity over the scalp that is ipsilateral to motor activity is very small and difficult to identify as compared with that occurring contralaterally. Recording responses directly from the cortical surface would improve the ability to identify this activity. An occasion that would allow us such an opportunity would be invasive monitoring in patients with epilepsy.
Epileptic patients who are surgical candidates, but require more precise localization of epileptogenic zones, typically undergo long-term video-EEG monitoring with subdural and/or depth electrodes. Some patients may have seizure onsets close to the sensory-motor area of the brain and require functional mapping in terms of motor function. We would like the opportunity to study electrocorticographic (ECoG) activity associated with simple movements in these patients who are undergoing invasive monitoring.
This study will not disturb ongoing monitoring, nor endanger the patient since no activation or stimulation is involved.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Epileptic patients who are undergoing invasive recording with implanted subdural electrodes that cover the sensorimotor cortices.
- Therefore, we will recruit only those patients with medically intractable epilepsy who are candidates for surgical treatment, and in whom invasive monitoring was deemed necessary for the purpose of precise localization of epileptogenic zones.
Key exclusion criteria (2 listed)
- Patients whose electrode implantation does not cover the sensorimotor cortices.
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 8598174Andrew C, Pfurtscheller G. Event-related coherence as a tool for studying dynamic interaction of brain regions. Electroencephalogr Clin Neurophysiol. 1996 Feb;98(2):144-8. doi: 10.1016/0013-4694(95)00228-6.
- Background: PubMed 8788955Conway BA, Halliday DM, Farmer SF, Shahani U, Maas P, Weir AI, Rosenberg JR. Synchronization between motor cortex and spinal motoneuronal pool during the performance of a maintained motor task in man. J Physiol. 1995 Dec 15;489 ( Pt 3)(Pt 3):917-24. doi: 10.1113/jphysiol.1995.sp021104.
- Background: PubMed 10574289Bartolomei F, Wendling F, Vignal JP, Kochen S, Bellanger JJ, Badier JM, Le Bouquin-Jeannes R, Chauvel P. Seizures of temporal lobe epilepsy: identification of subtypes by coherence analysis using stereo-electro-encephalography. Clin Neurophysiol. 1999 Oct;110(10):1741-54. doi: 10.1016/s1388-2457(99)00107-8.
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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 Epilepsy, 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 2 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 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 NCT00036595, 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 4 Mar 2008.