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ALS/MND Natural History Study Data Repository

NCT05966038 · Massachusetts General Hospital
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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 * Longitudinal clinical and phenotypical data from routine clinical visits * Longitudinal clinical and historical phenotypical data transcribed from electronic health records and notes * Any other observational data that are of interest to the Investigator may be captured or linked to information in NeuroBANK. 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.
Eligibility criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Disease does not meet criteria for any motor neuron disorder
Study design
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2015-04-01
Estimated completion: 2030-12-31
Last updated: 2025-11-14
Primary outcomes
  • ALS Functional Rating Scale-Revised (ALSFRS-R) (Every 3-4 months up to 5 years)
  • Slow Vital Capacity (SVC) (Every 3-4 months up to 5 years)
  • Survival (Every 3-4 months up to 5 years)
Sponsor
Massachusetts General Hospital · other
With: Henry Ford Health System, Northwestern University, Temple University, St. Louis University, University of Florida, University of Minnesota, Virginia Commonwealth University, Fondazione Serena Onlus - Centro Clinico NeMO Milano, Providence Health & Services, University of Pittsburgh, Istituti Clinici Scientifici Maugeri SpA, Lahey Clinic, Hadassah Medical Organization, Tel Aviv Medical Center, Kaiser Permanente
Contacts & investigators
ContactNatalia Tarasenko · contact · ntarasenko@mgh.harvard.edu · 1617240346
InvestigatorAlexander Sherman · principal_investigator, Massachusetts General Hospital
All locations (16)
Loma Linda University HealthRecruiting
Loma Linda, California, United States
Kaiser PermanenteRecruiting
Los Angeles, California, United States
University of FloridaRecruiting
Gainesville, Florida, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Lahey ClinicRecruiting
Burlington, Massachusetts, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Saint Louis UniversityRecruiting
St Louis, Missouri, United States
Providence ALS ClinicRecruiting
Portland, Oregon, United States
Temple University Lewis Katz School of MedicineRecruiting
Philadelphia, Pennsylvania, United States
University of PittsburghRecruiting
Pittsburgh, Pennsylvania, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States
Hadassah Medical OrganizationRecruiting
Jerusalem, Israel
Tel Aviv Medical CenterRecruiting
Tel Aviv, Israel
Centro Clinico NEMO MilanoRecruiting
Milan, Italy
Istituti Clinici Scientifici Maugeri SpARecruiting
Milan, Italy
ALS/MND Natural History Study Data Repository · TrialPath