Brain Function in Primary Lateral Sclerosis
|First Received Date ICMJE||October 22, 2003|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||October 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00071435 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Brain Function in Primary Lateral Sclerosis|
|Official Title ICMJE||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.
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.
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 Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Motor Neuron Disease|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Healthy adult volunteers ages 40-75 who are willing to participate.
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00071435|
|Other Study ID Numbers ICMJE||040017, 04-N-0017|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP