Multicenter ALS Cohort Study of Oxidative Stress and Disease Progression

Study ID
STU 122011-025

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Nina Gorham
214-648-0462
nina.gorham@utsouthwestern.edu

Principal Investigator
Sharon Nations

Summary

The study design is a prospective multicenter cohort study of 420 patients with aLS. Study subjects will have a baseline visit and follow up visits at months 3, 6, 12, 18 and 24 months. The study will measure survival at 30 months. These visits are timed to correspond to the typical pattern of aLS patient clinic visits. at or around the time of each of these visits, the subjects will give fasting urine and fasting blood samples to the researchers and will be interviewed about recent and current environmental exposures, lifestyle, and psychological stress. Clinical measures will also be taken at these visits. at baseline and months 6, 12 and 24, the patient will complete a food questionnaire. Skin samples and epigenetic blood will be collected at baseline or at the next occurring visit for participants already enrolled. one or two patients at each site will be enrolled each month to assure even enrollment throughout the seasons.

Participant Eligibility

1) have a diagnosis of sALS and other subtypes (PMA and pure UMN/suspected PLS).
2) have disease duration of 18 months or less after symptom onset. Symptoms at onset are defined as self-reported subjective weakness of the skeletal or bulbar muscles, excluding fasciculations or cramps.
3) are at least age 20 years. Both genders and all ethnic and racial groups will be included.
4) have spinal- OR bulbar-onset ALS.
5) have a reliable family care partner (biologic relative, spouse or domestic partner, or other unpaid household member) who, if necessary, can assist the patient in providing response on telephone interviews and questionnaires. This care partner will also sign the consent form as an indication of their willingness to provide this assistance and to complete certain questionnaires on the patient[Single Quote]s cognitive abilities and level of psychological stress.
5) are fluent in English.
6) have the capacity to consent: are able to understand and sign the Informed Consent approved by the IRB at each study site and also sign the form for HIPAA regulations. The patient[Single Quote]s capacity is measured using the Capacity Assessment Record for Informed Consent (CAR) (appended).
7) are willing to return to the site for the follow-up examinations.