Brain Function in Primary Lateral Sclerosis

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00071435
First received: October 22, 2003
Last updated: March 3, 2008
Last verified: February 2006
  Purpose

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.


Condition
Motor Neuron Disease

Study Type: Observational
Official Title: Movement Related Cortical Potentials in Primary Lateral Sclerosis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 36
Study Start Date: October 2003
Estimated Study Completion Date: February 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

Patients

  1. Ages 40-75
  2. Fulfill the proposed diagnostic criteria for PLS of Pringle 1992.
  3. Have an ascending course of symptom progression.
  4. Slow hand movements, as determined by measuring finger-tapping speeds of 20-65 taps in 15 s.
  5. 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.

EXCLUSION CRITERIA:

  1. Neurological diseases or conditions other than PLS.
  2. Implanted devices, such as pumps, pacemakers, or metal fragments in the skull or eye.
  3. Pregnancy as determined by urine pregnancy test within 48 hours of MRI study in women of childbearing
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00071435

Locations
United States, Maryland
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00071435     History of Changes
Other Study ID Numbers: 040017, 04-N-0017
Study First Received: October 22, 2003
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
EEG
Voluntary Movement
Motor Cortex
Reaction Time
Corticospinal
Primary Lateral Sclerosis
PLS
Healthy Volunteer
HV

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on April 17, 2014