HealthyNCT00029939
Brain Activity During Production of Movement
An observational study of Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use electroencephalography (EEG) to examine how the brain prepares for movement. It will look at 1) what changes occur in a person's brain just before voluntary movement, 2) when the changes occur, 3) how consistent the changes are, and 4) how the changes vary from person to person. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2002to 23 Nov 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HEALTHY VOLUNTEERS:
- Healthy volunteers will be over 18, and willing to participate, and able to give informed consent.
- STROKE PATIENTS:
- The stroke patients will have a clinically and radiologically documented stroke in the sub-acute (2 weeks to 6 months to after onset) or the chronic state (more than 6 months after onset), having a lesion in sub-cortical regions including the basal ganglia, thalamus, internal capsule, or a combination of these structures, or cerebellum unilaterally. These lesions can extend to the surrounding areas, however not including the cortical areas. Patients will be over 18 years of age.
- PLS/ALS PATIENTS:
- Patients must fulfill the diagnostic criteria proposed by Pringle (1992) for PLS and have been diagnosed with PLS for at least 3 years. Criteria include onset of spasticity alone in adulthood, slow progressive course, no family history, no lower motor neuron signs, and exclusion of known causes of spasticity. ALS patients should have probable or definite ALS by El Escorial criteria. Patients must have evidence of upper and lower motor neuron signs in two or more defined regions: cranial, arms, legs, or torso. Only the PLS/ALS patients who have recently participated in the study under protocol 06-N-0174 will be included. Some subjects will be studied as inpatients.
Who cannot join
- HEALTHY VOLUNTEERS:
- Subjects who are unable to perform simple voluntary movement with both hands.
- Subjects who have any neurological or psychiatric conditions.
- Subjects who have any implanted metal in or on their bodies that cannot be removed prior to the MRI and MEG scans.
- STROKE PATIENTS:
- We are investigating a particular EEG pattern associated with voluntary movement that we believe may not be present in patients with multiple strokes that involve the cerebral cortex; therefore, we will exclude this population of stroke patients. We will, however, include patients with multiple strokes if the cerebral cortex was not involved because we hypothesize that the EEG pattern that we are looking for will be preserved in patients with sub-cortical stroke lesions.
Show all 13Show fewer
- Patients with MRI findings consistent with brain tumors, trauma or AVMs will be excluded.
- Patients with multiple stroke lesions that involve the cerebral cortex will be excluded.
- Subjects with a pre-stroke history of schizophrenia or bipolar disorders will be excluded.
- Subjects with cancer will be excluded.
- Patients not capable of giving an informed consent will be excluded.
- PLS/ALS PATIENTS:
- PLS/ALS patients with a history or evidence of a coexisting or other neurological disorder, such as stroke, epilepsy, Parkinson's disease, polio, ataxia or neuropathy, or a history of traumatic brain injury, skull defects or neurosurgery will be excluded. PLS/ALS patients will have neuropsychological tests of frontal cortex function under protocol 06-N-0174. Patients with scores below 133 (out of 144) on the Mattis dementia rating scale will be classified as impaired patients who are unable to give their own informed consent and will be excluded. PLS/ALS patients who are unable to travel will be excluded. PLS/ALS patients who are respirator dependent will be excluded.
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: Real-Time Analysis of Scalp Electroencephalography and Magnetoencephalography During Production of Human Voluntary Movement
This study will use electroencephalography (EEG) to examine how the brain prepares for movement. It will look at 1) what changes occur in a person's brain just before voluntary movement, 2) when the changes occur, 3) how consistent the changes are, and 4) how the changes vary from person to person. The information from this study will be applied to other studies, such as exploring how brain changes that signal movement can be used to control prostheses in patients with spinal cord injuries or stroke.
Healthy normal volunteers 18 years of age and older may be eligible for this study. People with neurologic or psychiatric disorders and people taking medicines that may affect brain signals (e.g., Valium) may not participate.
Participants will come to the NIH Clinical Center on two separate days for testing sessions of 2 to 3 hours each. At each session, an EEG cap will be placed on the head to record brain signals, and electrodes will be placed on the arms to record movement. Subjects will perform simple movements during the EEG recording, such as flexing their arm of clenching their fist. Researchers will use the first recording to determine the pattern of how the brain prepares for movement. During the second recording, they will try to predict the subjects' movements, based on the patterns discerned in the first recording.
Read the detailed description
Human voluntary movement is associated with at least two distinct types of scalp electroencephalographic (EEG) changes. Event-related potentials are slow, with DC signals developing in the bifrontal region as early as 1.5 seconds prior to movement. They are detected by averaging multiple events in the time domain and generally require at least 40-50 events to allow detection of the signal within the noise. Frequency changes however, are more robust and may be seen reliably on individual traces. The frequency changes occur in the alpha (8-13 Hz) range as well as beta (13-30 Hz) and may occur up to 2 seconds before movement. This leads to the notion that real-time analysis of the EEG may allow one to predict individual movement. If this could be done reliably, it may provide further insight about how the brain prepares for movement, as well as potential therapeutic options such as control of cortically based prosthetic device.
Our initial study, henceforth Phase 1, is an exploratory study using real-time EEG to identify the factors that allow one to reliably predict normal human voluntary movement. Subjects will be normal volunteers, studied in the EEG lab in the Human Motor Control Section. Subjects will be asked to perform a simple motor task involving a sequence of finger movements while undergoing a routine EEG recording with surface electromyography. The EEG will then be processed using standard techniques to identify the location and time course of EEG signals in response to movement. Once this has occurred, subjects will return for a real-time study that will use their individually identified factors to predict their movement. The effects of training on the accuracy of prediction will also be explored by scheduling multiple real-time prediction sessions per subject over the course of several weeks. The rate of successful movement prediction will be the primary outcome measure.
After we are able to accurately predict movement intention with healthy volunteers, i.e., the false positive rate is under 20% with the false negative rate under 50%, we will study whether we can achieve the same prediction accuracy with stroke patients and patients with primary lateral sclerosis (PLS) or amyotrophic lateral sclerosis (ALS). The stroke patients and ALS/PLS patients will perform the same procedure as the subjects in the Phase 1 part of the trial.
Phase 2 of the investigation will extend to a different type of movement, reaching, and to an additional parameter, the spatial field of the intended target of the movement. In addition, Phase 2 will also include magnetoencephalography (MEG) as well as EEG methods to classify the spatiotemporal features of these movement parameters. Successful prediction of the intended goals of reaches to either ipsilateral or contralateral fields, prior to the onset of movement will be the main outcome measure of phase 2 of the study.
In Phase 3 of the investigation, healthy volunteers will perform a simple finger movement task which will be analyzed with special attention given to the timing of the intention to move and to how the intention affects the EEG signal. In order to assess whether spontaneous movements without prior instruction are associated with different physiological markers from typical self-paced paradigms, a recording session will be performed after the EEG cap is placed without instructing the subject.
Results from this study will then be used to design further protocols studying human voluntary movement and clinical applications as appropriate.
- Conditions
- Healthy
- Keywords
- Preparation, Subconscious, Healthy Volunteer, HV, Normal Control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2002 (estimated)
- Study start22 Jan 2002
- Study completion23 Nov 2010
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 HealthyStudies 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
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029939
- Sponsor's protocol ID
- 020109
- Other IDs
- 02-N-0109
- Status last verified
- 23 Nov 2010
- First submitted
- 26 Jan 2002
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Cohen LG, Bandinelli S, Sato S, Kufta C, Hallett M. Attenuation in detection of somatosensory stimuli by transcranial magnetic stimulation. Electroencephalogr Clin Neurophysiol. 1991 Oct;81(5):366-76. doi: 10.1016/0168-5597(91)90026-t.
PubMed 1718723Guger C, Ramoser H, Pfurtscheller G. Real-time EEG analysis with subject-specific spatial patterns for a brain-computer interface (BCI). IEEE Trans Rehabil Eng. 2000 Dec;8(4):447-56. doi: 10.1109/86.895947.
PubMed 11204035Haggard P, Eimer M. On the relation between brain potentials and the awareness of voluntary movements. Exp Brain Res. 1999 May;126(1):128-33. doi: 10.1007/s002210050722.
PubMed 10333013
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
- Real-Time Analysis of Scalp Electroencephalography and Magnetoencephalography During Production of Human Voluntary Movement
- ClinicalTrials.gov ID
- NCT00029939
- Acronym / sponsor ID
- 020109
- Conditions
- Healthy
- Keywords
- Preparation, Subconscious, Healthy Volunteer, HV, Normal Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 22 Jan 2002
- Study completion
- 23 Nov 2010
- First posted
- 28 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 electroencephalography (EEG) to examine how the brain prepares for movement. It will look at 1) what changes occur in a person's brain just before voluntary movement, 2) when the changes occur, 3) how consistent the changes are, and 4) how the changes vary from person to person. The information from this study will be applied to other studies, such as exploring how brain changes that signal movement can be used to control prostheses in patients with spinal cord injuries or stroke.
Healthy normal volunteers 18 years of age and older may be eligible for this study. People with neurologic or psychiatric disorders and people taking medicines that may affect brain signals (e.g., Valium) may not participate.
Participants will come to the NIH Clinical Center on two separate days for testing sessions of 2 to 3 hours each. At each session, an EEG cap will be placed on the head to record brain signals, and electrodes will be placed on the arms to record movement. Subjects will perform simple movements during the EEG recording, such as flexing their arm of clenching their fist. Researchers will use the first recording to determine the pattern of how the brain prepares for movement. During the second recording, they will try to predict the subjects' movements, based on the patterns discerned in the first recording.
Detailed description
Human voluntary movement is associated with at least two distinct types of scalp electroencephalographic (EEG) changes. Event-related potentials are slow, with DC signals developing in the bifrontal region as early as 1.5 seconds prior to movement. They are detected by averaging multiple events in the time domain and generally require at least 40-50 events to allow detection of the signal within the noise. Frequency changes however, are more robust and may be seen reliably on individual traces. The frequency changes occur in the alpha (8-13 Hz) range as well as beta (13-30 Hz) and may occur up to 2 seconds before movement. This leads to the notion that real-time analysis of the EEG may allow one to predict individual movement. If this could be done reliably, it may provide further insight about how the brain prepares for movement, as well as potential therapeutic options such as control of cortically based prosthetic device.
Our initial study, henceforth Phase 1, is an exploratory study using real-time EEG to identify the factors that allow one to reliably predict normal human voluntary movement. Subjects will be normal volunteers, studied in the EEG lab in the Human Motor Control Section. Subjects will be asked to perform a simple motor task involving a sequence of finger movements while undergoing a routine EEG recording with surface electromyography. The EEG will then be processed using standard techniques to identify the location and time course of EEG signals in response to movement. Once this has occurred, subjects will return for a real-time study that will use their individually identified factors to predict their movement. The effects of training on the accuracy of prediction will also be explored by scheduling multiple real-time prediction sessions per subject over the course of several weeks. The rate of successful movement prediction will be the primary outcome measure.
After we are able to accurately predict movement intention with healthy volunteers, i.e., the false positive rate is under 20% with the false negative rate under 50%, we will study whether we can achieve the same prediction accuracy with stroke patients and patients with primary lateral sclerosis (PLS) or amyotrophic lateral sclerosis (ALS). The stroke patients and ALS/PLS patients will perform the same procedure as the subjects in the Phase 1 part of the trial.
Phase 2 of the investigation will extend to a different type of movement, reaching, and to an additional parameter, the spatial field of the intended target of the movement. In addition, Phase 2 will also include magnetoencephalography (MEG) as well as EEG methods to classify the spatiotemporal features of these movement parameters. Successful prediction of the intended goals of reaches to either ipsilateral or contralateral fields, prior to the onset of movement will be the main outcome measure of phase 2 of the study.
In Phase 3 of the investigation, healthy volunteers will perform a simple finger movement task which will be analyzed with special attention given to the timing of the intention to move and to how the intention affects the EEG signal. In order to assess whether spontaneous movements without prior instruction are associated with different physiological markers from typical self-paced paradigms, a recording session will be performed after the EEG cap is placed without instructing the subject.
Results from this study will then be used to design further protocols studying human voluntary movement and clinical applications as appropriate.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy volunteers will be over 18, and willing to participate, and able to give informed consent.
- The stroke patients will have a clinically and radiologically documented stroke in the sub-acute (2 weeks to 6 months to after onset) or the chronic state (more than 6 months after onset), having a lesion in sub-cortical regions including the basal ganglia, thalamus, internal capsule, or a combination of these structures, or cerebellum unilaterally. These lesions can extend to the surrounding areas, however not including the cortical areas. Patients will be over 18 years of age.
- Patients must fulfill the diagnostic criteria proposed by Pringle (1992) for PLS and have been diagnosed with PLS for at least 3 years. Criteria include onset of spasticity alone in adulthood, slow progressive course, no family history, no lower motor neuron signs, and exclusion of known causes of spasticity. ALS patients should have probable or definite ALS by El Escorial criteria. Patients must have evidence of upper and lower motor neuron signs in two or more defined regions: cranial, arms, legs, or torso. Only the PLS/ALS patients who have recently participated in the study under protocol 06-N-0174 will be included. Some subjects will be studied as inpatients.
Key exclusion criteria (13 listed)
- Subjects who are unable to perform simple voluntary movement with both hands.
- Subjects who have any neurological or psychiatric conditions.
- Subjects who have any implanted metal in or on their bodies that cannot be removed prior to the MRI and MEG scans.
- We are investigating a particular EEG pattern associated with voluntary movement that we believe may not be present in patients with multiple strokes that involve the cerebral cortex; therefore, we will exclude this population of stroke patients. We will, however, include patients with multiple strokes if the cerebral cortex was not involved because we hypothesize that the EEG pattern that we are looking for will be preserved in patients with sub-cortical stroke lesions.
- Patients with MRI findings consistent with brain tumors, trauma or AVMs will be excluded.
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 1718723Cohen LG, Bandinelli S, Sato S, Kufta C, Hallett M. Attenuation in detection of somatosensory stimuli by transcranial magnetic stimulation. Electroencephalogr Clin Neurophysiol. 1991 Oct;81(5):366-76. doi: 10.1016/0168-5597(91)90026-t.
- Background: PubMed 11204035Guger C, Ramoser H, Pfurtscheller G. Real-time EEG analysis with subject-specific spatial patterns for a brain-computer interface (BCI). IEEE Trans Rehabil Eng. 2000 Dec;8(4):447-56. doi: 10.1109/86.895947.
- Background: PubMed 10333013Haggard P, Eimer M. On the relation between brain potentials and the awareness of voluntary movements. Exp Brain Res. 1999 May;126(1):128-33. doi: 10.1007/s002210050722.
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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, 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 6 inclusion and 13 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 NCT00029939, 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.