An observational study in ALS, PLS and MND (Motor Neurone DIsease), sponsored by Massachusetts General Hospital. Recruiting at 18 sites in 3 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Massachusetts General Hospital · Observational
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.
Most people with ALS or MND who are seen clinically by the PI or PI designees at participating sites will be recruited into this study. This well-established framework provides an opportunity to offer to a large proportion of people with ALS/MND a chance to participate in a clinical research project.
Upon obtaining consent, the following is done:
People with ALS/MND are assigned a Neurological Global Unique Identifier (NeuroGUID) and its study-specific derivative, NeuroSTAmP, which is used to link this Study's information to biological samples, images, and clinical data obtained from those individuals in this Study and other studies/trials, in which these patients participate(d).
The following information is captured in NeuroBANK platform:
Baseline information
Other Key Features
The site should track numbers of patients who declined participation. The site should have a mechanism in place to include an offer of participation to each patient in clinic (consenting does not require immediate data entry) Regular Data Quality checks may be performed at the site. Site personnel who intend to have access to NeuroBANK are trained and certified prior to given access.
Several registries, both cross-sectional and longitudinal, currently exist in ALS. NeuroBANK is distinct from other current registries in that it is a patient-centered platform that is designed to function as a data repository of patient data from clinical visits and multiple clinical research projects as well as linking these data to biorepository for tissue, imaging, and other biological information. This natural history study can act as a clinical research framework that may link clinical and clinical research data from current and past studies with biological specimens and image collections.
With obtained consents, biological specimens may be collected with bar-coded labels containing patient assigned study specific NeuroSTAmPs, printed from within NeuroBANK, and scanned into NeuroBANK's virtual distributed BioRepository module. Imaging studies are de-identified with NeuroSTAmPs and linked to clinical and phenotypical information. Anonymized clinical data obtained through this protocol are available to other researchers.
Study Population
Individuals who are seen during their clinical care visits are asked to allow their data to be uploaded and captured for clinical research. The NeuroBANK platform is located at and managed by the Center for Innovation and Bioinformatics (CIB), Neurological Clinical Research Institute (NCRI) of Massachusetts General Hospital (Boston, MA).
Consent Process
Every participant in the ALS clinic is approached to participate in this study. A signed informed consent form is obtained before any data are recorded for study purposes.
All people living with ALS/MND at participating multidisciplinary ALS/MND clinics
Exclusion Criteria:
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.
Time frame: Every 3-4 months up to 5 years
Slow Vital Capacity (SVC)
Slow vital capacity test normalized to age, sex, and height
Time frame: Every 3-4 months up to 5 years
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..
Time frame: Every 3-4 months up to 5 years
Vital Signs
Vital Signs (Weight, BP, HR). Both systolic and diastolic pressure are measured.
Time frame: Every 3-4 months up to 5 years
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
Time frame: Through study completion, annually up to 5 years
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.
Time frame: Through study completion, annually up to 5 years
Handheld Dynamometry
Handheld Dynamometry for quantitative strength testing of 18 muscles that is a reliable and reproducible measure of decline in ALS
Time frame: Every 3-4 months up to 5 years
Grip Strength Testing
Grip Strength Testing
Time frame: Every 3-4 months up to 5 years
Rasch Overall ALS Disability Scale (ROADS)
Rasch Overall ALS Disability Scale, the ROADS provides a normed total score on 28 items from 0-146 to capture overall disability level in a linearly-weighted manner, with lower scores indicating disease progression
Time frame: Every 3-4 months up to 5 years
5 Times Sit to Stand
5 Times Sit to Stand Test
Time frame: Every 3-4 months up to 5 years
10 Meter Walk Test
10 Meter Walk Test
Time frame: Every 3-4 months up to 5 years
Physical Examination
Physical Examination that includes the following test areas for abnormality and clinical significance: respiratory, cardio, gastrointestinal, genitourinary. and musculoskeletal
Time frame: Through study completion, annually up to 5 years
Plan to share: Yes — Anonymized IPD are being shared with data requestors upon submission of the research proposal online. Data Access Committee reviews submissions and upon approval and execution of the Data Sharing Agreement, the dataset is provided to the data requestor.
Supporting information: Study protocol
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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