NCT00014976

Brief Summary

This study will provide information about changes that occur in the motor neurons of the spinal cord (the nerve cells that control the muscles) when the motor cortex (the region of the brain that controls movement) is unable to send messages to the spinal cord and muscles in the normal way. This information will help elucidate how the nervous system adapts after injury or disease of the motor cortex. Healthy adult volunteers and adults with a spasticity disorder and moderate weakness may be eligible for this study. Patients will be screened with a medical history, physical examination and diagnostic studies as needed. Healthy volunteers will have a neurological examination. Muscle weakness and spasticity will be evaluated in both groups of subjects. All participants will have electromyography (measurement of electrical activity in muscles) during nerve stimulation and transcranial magnetic stimulation, described below. (Some patients, such as those with a pacemaker or implanted medication pumps, metal objects in the eye, history of epilepsy and others, will not have magnetic stimulation.) Electromyography - The electrical activity of muscles will be measured either by 1) using metal electrodes taped to the skin overlying a muscle, or 2) using thin wires inserted into the muscle through a needle. Nerve stimulation - The nerves will be stimulated by applying a small electrical pulse through metal disks on the skin of the arm or leg. Transcranial magnetic stimulation - A brief electrical current is passed through a wire coil placed on the scalp. This creates a magnetic pulse, which stimulates the brain. During the test, the participant may be asked to tense certain muscles slightly or perform other simple actions. Nerve block - Some patients will have a nerve block of one of the nerves in the arm. For this procedure, a local anesthetic is injected under the skin to produce numbness and weakness in some arm muscles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2001

Longer than P75 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

April 13, 2001

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2001

Completed
9.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 2, 2017

Status Verified

November 1, 2010

First QC Date

April 17, 2001

Last Update Submit

June 30, 2017

Conditions

Keywords

Pyramidal TractPrimary Lateral SclerosisSpastic ParaparesisEMGMagnetic StimulationMuscle SpasticityHealthy Volunteer

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with selective corticospinal tract dysfunction
  • Minimum age 21 years; maximum age 80 years
  • Moderate severity of weakness (greater than or equal to MRC Grade 4)
  • Adult normal volunteers

You may not qualify if:

  • Severe weakness with inability to maintain voluntary contractions
  • Significant sensory impairment
  • For TMS studies only: pregnancy, implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except the mouth, intracardiac lines, history of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Gemperline JJ, Allen S, Walk D, Rymer WZ. Characteristics of motor unit discharge in subjects with hemiparesis. Muscle Nerve. 1995 Oct;18(10):1101-14. doi: 10.1002/mus.880181006.

    PMID: 7659104BACKGROUND
  • Rosenfalck A, Andreassen S. Impaired regulation of force and firing pattern of single motor units in patients with spasticity. J Neurol Neurosurg Psychiatry. 1980 Oct;43(10):907-16. doi: 10.1136/jnnp.43.10.907.

    PMID: 7441270BACKGROUND
  • Frascarelli M, Mastrogregori L, Conforti L. Initial motor unit recruitment in patients with spastic hemiplegia. Electromyogr Clin Neurophysiol. 1998 Jul-Aug;38(5):267-71.

    PMID: 9741003BACKGROUND

MeSH Terms

Conditions

Muscle SpasticityMotor Neuron DiseaseParaparesis, Spastic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodegenerative DiseasesNeuromuscular DiseasesParaparesisParesis

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

April 17, 2001

First Posted

April 18, 2001

Study Start

April 13, 2001

Study Completion

November 1, 2010

Last Updated

July 2, 2017

Record last verified: 2010-11-01

Locations