NCT00071435

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

March 4, 2008

Status Verified

February 1, 2006

First QC Date

October 22, 2003

Last Update Submit

March 3, 2008

Conditions

Keywords

EEGVoluntary MovementMotor CortexReaction TimeCorticospinalPrimary Lateral SclerosisPLSHealthy VolunteerHV

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 10540028BACKGROUND
  • Swash 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.

    PMID: 10540029BACKGROUND
  • Sasaki 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.

    PMID: 11787823BACKGROUND

MeSH Terms

Conditions

Motor Neuron Disease

Condition Hierarchy (Ancestors)

Neurodegenerative DiseasesNervous System DiseasesNeuromuscular Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 22, 2003

First Posted

October 23, 2003

Study Start

October 1, 2003

Study Completion

February 1, 2006

Last Updated

March 4, 2008

Record last verified: 2006-02

Locations