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

Study Focus:
To study the relation of oxidative stress to the diagnosis and progression of motor neuron disease.

Disease:
Primary Lateral Sclerosis (PLS)

Study Category:
Epidemiology (risk factor)

Study Status:
Active, no longer recruiting

Not Applicable

Type:

Funding Source:
National Institute of Neurological Disorders and Stroke (NINDS)

Study Chair(s)/Principal Investigator(s):
Mary Kay Floeter, M.D. (National Institute of Neurological Disorders and Stroke)

Clinicaltrials.gov ID:
NCT01143428

NEALS Affiliated?
No

Study Summary:
Patients will undergo a standard battery of clinical, physiological, and cognitive screening tests at enrollment, with scheduled follow-up evaluation visits every 12 months for 36 months. Blood and urine samples will be sent to collaborators at Columbia University for analysis of markers of oxidative injury and genetic risk factors. Patients will complete a self-administered nutritional survey and will be interviewed by phone by Columbia University investigators using questionnaires to assess environmental, occupational, lifestyle and psychosocial factors thought to be triggers of oxidative stress.

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.

Participant Duration:
36 months

# of Subjects:
15

Enrollment Start Date:
05/01/2010

Enrollment End Date:
12/01/-0001

Posting Last Modified Date:
11/01/2011

Date Study Added to alscortium.org:
11/16/2011

Eligibility Criteria

Gender:
Male & Female

Minimum Age:
20

N/A

Time since Symptom Onset:
More than 36 months

Time since Diagnosis:
Not applicable

Coordinating Center
Contact Information

Mary Kay Floeter, M.D.

floeterm@ninds.nih.gov

(301) 496-7428

National Institutes of Health Clinical Center

9000 Rockville Pike
Bethesda, Maryland 20892
UNITED STATES

Other Eligibility Criteria:
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


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

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