The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is being funded by the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases. ASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.
Study Type
OBSERVATIONAL
Enrollment
2,000
University of Alabama Birmingham
Birmingham, Alabama, United States
RECRUITINGBarrow Neurological Institute
Phoenix, Arizona, United States
RECRUITINGUniversity of California, Irvine
Irvine, California, United States
RECRUITINGUniversity of California San Diego
La Jolla, California, United States
ALS Functional Rating Scale-Revised (ALSFRS-R)
Questionnaire administered by a clinician that includes a series of questions about participants' ability to function in certain daily activities. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Time frame: Baseline, 4, 8, 12, 16, 20 and 24 months for ALS participants only.
ALS Functional Rating Scale-Revised Self entry (ALSFRS-RSE)
Questionnaires completed by participants that includes questions about participants ability to function in certain daily activities. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Time frame: Baseline, 2, 4 ,6, 8, 10, 12, 14,16, 18,20, 22 and 24 months for ALS participants only
ALS Impairment Multidomain scale (AIMS)
Questionnaires completed by participants that assess severity of the ALS disease
Time frame: 1, 3, 5,7,9,11,13,15,17,19,21 and 23 months from baseline for ALS participants only
Social Determinants of Health
Questionnaires completed by participants that includes questions about non-medical factors that affect health outcomes
Time frame: Months 3 and 4 for all cohorts
Environmental History
Questionnaires completed by participants that includes questions about environmental exposures such as chemicals, smoking, alcohol etc.
Time frame: Month 1 for all cohorts
Cognitive assessment (ECAS)
ECAS is a multi-domain assessment administered by study staff, to evaluate different aspects of cognitive function
Time frame: Baseline, 12 and 24 months for all cohorts
Vital Capacity
Change in respiratory function over time as measured by Slow Vital Capacity (SVC).
Time frame: Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants
Digital Speech Assessment
Participants will be asked to record voice samples at home once a month using a digital application installed on their device.
Time frame: Baseline, and monthly (at month 1,2, 3 through month 24 from baseline)
HHD of 3 hand muscles bilaterally
Hand-held dynamometry (HHD) will be used as a quantitative measure of muscle strength for the three intrinsic hand muscles, bilaterally
Time frame: Baseline, 4,8,12,16,20 and 24 months for on-site ALS participants; Baseline, 12 and 24 months for control participants
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California, San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGHospital For Special Care
New Britain, Connecticut, United States
RECRUITINGGeorgetown University
Washington D.C., District of Columbia, United States
RECRUITINGMayo Clinic
Jacksonville, Florida, United States
RECRUITINGSaint Alphonsus Regional Medical Center
Boise, Idaho, United States
RECRUITING...and 22 more locations