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Oxidative Stress in Motor Neuron Disease: COSMOS Add-On Study

NCT01143428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2019-11-05

No results posted yet for this study

Summary

Background:

\- Primary lateral sclerosis (PLS) is a disorder in which nerve cells in the brain that control movement degenerate. The cause of PLS is not known, but some research has suggested that environmental factors that produce oxidative stress trigger PLS in people who carry certain genes. Oxidative stress is caused when the body makes chemicals called "free radicals" faster than its natural systems can break them down. Oxidative stress can be triggered by exposures to chemicals related to the bodily effects of lead, smoking, alcohol consumption, physical activity, and psychological stress. Chemicals produced by the body during oxidative stress can be measured in the blood and urine. Researchers are interested in studying the physical, neurological, and chemical effects of PLS to better understand the effects of oxidative stress on the disorder.

Objectives:

\- To study the relation of oxidative stress to the diagnosis and progression of motor neuron disease.

Eligibility:

\- Individuals 20 years of age or older who have been diagnosed with PLS, and have had symptoms of PLS for at least 5 but not more than 8 years and been previously enrolled in 01-N-0145 Screening: Neurologic Disorders with Muscle Stiffness

Design:

* Participants will have an initial study visit and three follow-up visits. Each visit will require approximately 3 days of testing at the National Institutes of Health Clinical Center.
* As part of this study, participants will have the following tests and procedures:
* Neurological examination to test muscle strength, sensation, coordination, and reflexes, as well as clarity of speech
* Tests of memory, attention, concentration, and thinking
* Surveys on oxidative stress, including questions on life, mood, jobs held, and habit
* Electromyography to record the electrical activity of muscles
* Transcranial magnetic stimulation to measure electrical activity translated from their brain to the muscles
* Blood, urine, and skin biopsy samples for testing and sample collection
* After the initial visit, participants will have three more visits, once each in the following 3 years.

Conditions

  • Motor Neuron Disease
  • Primary Lateral Sclerosis

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Mary Kay Floeter, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-13
Completion
2015-08-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143428 on ClinicalTrials.gov