Status:
COMPLETED
Oxidative Stress in Motor Neuron Disease: COSMOS Add-On Study
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Motor Neuron Disease
Primary Lateral Sclerosis
Eligibility:
All Genders
20+ years
Brief 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 en...
Detailed Description
Objective Primary lateral sclerosis (PLS) and amyotrophic lateral sclerosis (ALS) are motor neuron disorders with different phenotypes that progress at very different rates. ALS is a rapidly progress...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients will be included if they:
- Are 20 years or older
- Have PLS, that is pure UMN dysfunction (spasticity, pathological hyperreflexia, pathological reflexes with or without motor weakness) of undetermined etiology
- Have been evaluated at NIH and are being willing to return for active follow-up for 3 years
- Had PLS symptom onset at least 5 years prior to the study enrollment but not more than 15 years
- Have normal nerve conduction studies and normal needle electrode examination performed within 12 months of the time of enrollment in this study
- Have no other definable diseases causing spasticity such as structural brain or spinal cord disease, metabolic diseases, paraneoplastic syndromes, hereditary diseases, infectious diseases, or other significant neurological abnormalities
- Have a reliable family caregiver who can assist in providing responses on telephone interviews and questionnaires if the proband has problems with speaking or writing
- Are fluent in English
- Ability to provide his/her own informed consent
- EXCLUSION CRITERIA:
- Patients will be excluded if they:
- Have EMG evidence of active denervation or fasciculations in more than a few muscles with chronic neurogenic motor unit potentials at the time of enrollment
- Have only lower extremity involvement
- Have major medical diseases (e.g. active cancer, dialysis) that have required active medical treatment within the past 6 months
- Are participating in clinical treatment trials at the time of enrollment and acquisition of baseline biological samples (participation in clinical trials after the baseline visit is permitted)
- Are unwilling or unable to return for follow-up visits
- Have pacemakers or other implanted electrical devices, which might make TMS unsafe will be excluded from TMS testing
Exclusion
Key Trial Info
Start Date :
May 13 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 3 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01143428
Start Date
May 13 2010
End Date
August 3 2015
Last Update
November 5 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892