Motor Neuron DiseaseNCT00071435
Brain Function in Primary Lateral Sclerosis
An observational study of Motor Neuron Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine whether the motor cortex (the part of the brain that controls movement) works properly in patients with primary lateral sclerosis (PLS), a disorder in which voluntary movements are very slow. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Motor Neuron Disease
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Feb 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients
- Ages 40-75
- Fulfill the proposed diagnostic criteria for PLS of Pringle 1992.
- Have an ascending course of symptom progression.
- Slow hand movements, as determined by measuring finger-tapping speeds of 20-65 taps in 15 s.
- Absent motor evoked potentials in hand muscles with 100% output of the MagStim200 transcranial magnetic stimulator.
- Normal Volunteers
- Healthy adult volunteers ages 40-75 who are willing to participate.
Who cannot join
- Neurological diseases or conditions other than PLS.
- Implanted devices, such as pumps, pacemakers, or metal fragments in the skull or eye.
- Pregnancy as determined by urine pregnancy test within 48 hours of MRI study in women of childbearing
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: Movement Related Cortical Potentials in Primary Lateral Sclerosis
This study will examine whether the motor cortex (the part of the brain that controls movement) works properly in patients with primary lateral sclerosis (PLS), a disorder in which voluntary movements are very slow.
Healthy volunteers between 40 and 75 years of age and patients with ascending PLS (a subset of PLS) may be eligible for this study. Patients with ascending PLS have a slowing of finger-tapping movements that corresponds to a particular abnormality of certain neuronal (nerve cell) activity.
Read more
Participants perform a finger-tapping reaction time exercise while brain wave activity (electroencephalography, or EEG) and muscle activity (electroymogram, or EMG) are measured. The subject is seated in front of a computer screen. A signal appears on the screen and the subject taps a key as quickly as possible in response to the signal.
For the EEG, brain activity is recorded by placing electrodes (small metal discs) on the scalp with an electrode cap or glue-like substance. A conductive gel is used to fill the space between the electrodes and the scalp to make sure there is good contact between them. The brain waves are recorded while the subject taps his or her fingers very slowly. For the surface EMG, electrodes filled with a conductive gel are taped to the skin.
Participants also undergo magnetic resonance imaging (MRI). This test uses a strong magnetic field and radio waves to obtain images of the brain. During the procedure, the subject lies still on a table that can slide in and out of the scanner - a narrow metal cylinder. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Subjects can communicate with the MRI staff at all times during the scan and can ask to be moved out of the machine at any time.
Read the detailed description
Objective: Primary Lateral Sclerosis (PLS) is a clinical syndrome of progressive spasticity. Patients with PLS have slow voluntary movements. In PLS, degeneration of corticospinal tracts disrupts the communication between the motor cortex and motor neurons. Normally, voluntary movements are preceded by EEG waveform changes that begin before the movement occurs. These waveforms are called movement related cortical potentials (MRCPs). The first part of the MRCP represents neural activity in the motor cortex. The goal of this study is to determine whether the motor cortex and pre-motor cortex operate normally to generate these intrinsic signals for voluntary movement in patients with PLS.
Study population: Patients with PLS of at least 3 years duration with slow finger tapping movements will be studied. Patients must fulfill the clinical criteria for the ascending subtype of PLS. They must also have a loss of corticospinal excitability as measured by transcranial magnetic stimulation. Age matched normal volunteers will be studied as a control group.
Design: Patients and normal volunteers will undergo a session of EEG recording while making slow finger tapping movements. They will have an MRI of the brain, for the purpose of localizing dipole positions of the MRCP components.
Outcome parameters: The peak amplitudes of components of the MRCPs will be compared between patients and a healthy control group as the primary outcome measure. Localization of the dipoles of the components is a secondary outcome measure.
- Conditions
- Motor Neuron Disease
- Keywords
- EEG, Voluntary Movement, Motor Cortex, Reaction Time, Corticospinal, Primary Lateral Sclerosis, PLS, Healthy Volunteer, HV
- Medical subject headings
- Motor Neuron Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2003 (estimated)
- Study startOct 2003
- Study completionFeb 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 Motor Neuron DiseaseStudies 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
- 36 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
- NCT00071435
- Sponsor's protocol ID
- 040017
- Other IDs
- 04-N-0017
- Status last verified
- Feb 2006
- First submitted
- 22 Oct 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Rowland LP. Primary lateral sclerosis: disease, syndrome, both or neither? J Neurol Sci. 1999 Nov 15;170(1):1-4. doi: 10.1016/s0022-510x(99)00183-5. No abstract available.
PubMed 10540028Swash M, Desai J, Misra VP. What is primary lateral sclerosis? J Neurol Sci. 1999 Nov 15;170(1):5-10. doi: 10.1016/s0022-510x(99)00184-7.
PubMed 10540029Sasaki S, Iwata M. Ultrastructural study of Betz cells in the primary motor cortex of the human brain. J Anat. 2001 Dec;199(Pt 6):699-708. doi: 10.1046/j.1469-7580.2001.19960699.x.
PubMed 11787823
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
- Movement Related Cortical Potentials in Primary Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT00071435
- Acronym / sponsor ID
- 040017
- Conditions
- Motor Neuron Disease
- Keywords
- EEG, Voluntary Movement, Motor Cortex, Reaction Time, Corticospinal, Primary Lateral Sclerosis, PLS, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 2003
- Study completion
- Feb 2006
- First posted
- 23 Oct 2003 (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 whether the motor cortex (the part of the brain that controls movement) works properly in patients with primary lateral sclerosis (PLS), a disorder in which voluntary movements are very slow.
Healthy volunteers between 40 and 75 years of age and patients with ascending PLS (a subset of PLS) may be eligible for this study. Patients with ascending PLS have a slowing of finger-tapping movements that corresponds to a particular abnormality of certain neuronal (nerve cell) activity.
Participants perform a finger-tapping reaction time exercise while brain wave activity (electroencephalography, or EEG) and muscle activity (electroymogram, or EMG) are measured. The subject is seated in front of a computer screen. A signal appears on the screen and the subject taps a key as quickly as possible in response to the signal.
For the EEG, brain activity is recorded by placing electrodes (small metal discs) on the scalp with an electrode cap or glue-like substance. A conductive gel is used to fill the space between the electrodes and the scalp to make sure there is good contact between them. The brain waves are recorded while the subject taps his or her fingers very slowly. For the surface EMG, electrodes filled with a conductive gel are taped to the skin.
Participants also undergo magnetic resonance imaging (MRI). This test uses a strong magnetic field and radio waves to obtain images of the brain. During the procedure, the subject lies still on a table that can slide in and out of the scanner - a narrow metal cylinder. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Subjects can communicate with the MRI staff at all times during the scan and can ask to be moved out of the machine at any time.
Detailed description
Objective: Primary Lateral Sclerosis (PLS) is a clinical syndrome of progressive spasticity. Patients with PLS have slow voluntary movements. In PLS, degeneration of corticospinal tracts disrupts the communication between the motor cortex and motor neurons. Normally, voluntary movements are preceded by EEG waveform changes that begin before the movement occurs. These waveforms are called movement related cortical potentials (MRCPs). The first part of the MRCP represents neural activity in the motor cortex. The goal of this study is to determine whether the motor cortex and pre-motor cortex operate normally to generate these intrinsic signals for voluntary movement in patients with PLS.
Study population: Patients with PLS of at least 3 years duration with slow finger tapping movements will be studied. Patients must fulfill the clinical criteria for the ascending subtype of PLS. They must also have a loss of corticospinal excitability as measured by transcranial magnetic stimulation. Age matched normal volunteers will be studied as a control group.
Design: Patients and normal volunteers will undergo a session of EEG recording while making slow finger tapping movements. They will have an MRI of the brain, for the purpose of localizing dipole positions of the MRCP components.
Outcome parameters: The peak amplitudes of components of the MRCPs will be compared between patients and a healthy control group as the primary outcome measure. Localization of the dipoles of the components is a secondary outcome measure.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients
- Ages 40-75
- Fulfill the proposed diagnostic criteria for PLS of Pringle 1992.
- Have an ascending course of symptom progression.
- Slow hand movements, as determined by measuring finger-tapping speeds of 20-65 taps in 15 s.
Key exclusion criteria (3 listed)
- Neurological diseases or conditions other than PLS.
- Implanted devices, such as pumps, pacemakers, or metal fragments in the skull or eye.
- Pregnancy as determined by urine pregnancy test within 48 hours of MRI study in women of childbearing
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 10540028Rowland LP. Primary lateral sclerosis: disease, syndrome, both or neither? J Neurol Sci. 1999 Nov 15;170(1):1-4. doi: 10.1016/s0022-510x(99)00183-5. No abstract available.
- Background: PubMed 10540029Swash M, Desai J, Misra VP. What is primary lateral sclerosis? J Neurol Sci. 1999 Nov 15;170(1):5-10. doi: 10.1016/s0022-510x(99)00184-7.
- Background: PubMed 11787823Sasaki S, Iwata M. Ultrastructural study of Betz cells in the primary motor cortex of the human brain. J Anat. 2001 Dec;199(Pt 6):699-708. doi: 10.1046/j.1469-7580.2001.19960699.x.
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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 Motor Neuron Disease, 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 8 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 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 NCT00071435, 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.