This is a data repository for multi-site multi-protocol clinic-based Natural History Study of ALS and Other Motor Neuron Disorders (MND).
All people living with ALS or other MNDs who attend clinics at the Study hospitals (sites) are offered to participate in the Study.
The Sites collect so-called Baseline information including demographics, disease history and diagnosis, family history, etc. At each visit, the Sites also collect multiple disease-specific outcome measures and events. The information is captured in NeuroBANK, a patient-centric clinical research platform.
The Sites have an option to choose to collect data into 20+ additional forms capturing biomarkers and outcome measures. Captured data after its curation are anonymized (all personal identifiers and dates are being removed), and the anonymized dataset is shared with medical researchers via a non-exclusive revocable license.
Funding Source - Biogen, Inc.; Mitsubishi Tanabe Pharma America; FDA OOPD.
A clinical diagnosis of El Escorial of suspected, possible, probable, or definite ALS or
Other motor neuron disorders, including but not limited to Spinal-Bulbar Muscular Atrophy (SBMA, Kennedy's disease), Spinal Muscular Atrophy (SMA), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy (PBP)
Disease does not meet criteria for any motor neuron disorder
All people living with ALS/MND at participating multidisciplinary ALS/MND clinics
Other
Prospective
Not listed
ALS Functional Rating Scale-Revised (ALSFRS-R)
The ALS Functional Rating Scale revised is a 12-item rating scale that measures the progression of disability in patients with ALS. The ALSFRS-r assesses patients' levels of self-sufficiency in areas of feeding, grooming, ambulation and communication. The higher the score, the earlier in the disease progression. It consists of 12 questions with a maximum score of 48 points.
Slow Vital Capacity (SVC)
Slow vital capacity test normalized to age, sex, and height
Survival
Patient survival or survival equivalent (time to ventilator or feeding tube). Survival equivalent is assessed during routine clinical visits, while mortality event may be reported when becomes known to the treating clinician..
Vital Signs
Vital Signs (Weight, BP, HR). Both systolic and diastolic pressure are measured.
Neurological Examination
Neurological exam that tests for abnormality various areas, from general assessment to coordination and cerebellar function, to sensation and reflexes, to cranial nerves and plantar
El Escorial Criteria
The El Escorial criteria are diagnostic criteria for ALS. They classify patients into categories of possible, probable, or definite ALS, based on signs of degeneration of upper and lower motor neurons in different body regions.
Handheld Dynamometry
Handheld Dynamometry for quantitative strength testing of 18 muscles that is a reliable and reproducible measure of decline in ALS
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Henry Ford Health System
Collaborator
Northwestern University
Collaborator
Temple University
Collaborator
St. Louis University
Collaborator
University of Florida
Collaborator
University of Minnesota
Collaborator
Virginia Commonwealth University
Collaborator
Fondazione Serena Onlus - Centro Clinico NeMO Milano
Collaborator
Providence Health & Services
Collaborator
University of Pittsburgh
Collaborator
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Lahey Clinic
Collaborator
Hadassah Medical Organization
Collaborator
Tel Aviv Medical Center
Collaborator
Kaiser Permanente
Collaborator
Trinity Health Michigan
Collaborator
Thomas Jefferson University
Collaborator
