ALS/MND Natural History Study Data Repository

May 18, 2026 updated by: Alexander Sherman, Massachusetts General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Organization
        • Contact:
        • Principal Investigator:
          • Marc Gotkine, MD
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Medical Center
        • Contact:
        • Principal Investigator:
          • Vivian Drori, MD
  • Italy
      • Milan, Italy, 20162
      • Milan, Italy, 20138
        • Recruiting
        • Istituti Clinici Scientifici Maugeri SpA
        • Contact:
        • Principal Investigator:
          • Christian Lunetta, MD
        • Sub-Investigator:
          • Rachele Piras, MD
  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University health
        • Principal Investigator:
          • Jeffrey Rosenfeld, MD
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente
        • Contact:
        • Principal Investigator:
          • Abel Wu, MD
    • Florida
      • Gainesville, Florida, United States, 32610
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Senda Ajroud-Driss
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:
        • Principal Investigator:
          • Ximena Arcila Londono
      • Grand Rapids, Michigan, United States, 49503
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • David Walk
    • Missouri
      • St Louis, Missouri, United States, 63104
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence ALS Clinic
        • Contact:
        • Principal Investigator:
          • Nicholas Olney
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Principal Investigator:
          • Hristelina Ilieva, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Lewis Katz School of Medicine
        • Contact:
        • Principal Investigator:
          • Terry Heiman-Patterson
      • Pittsburgh, Pennsylvania, United States, 15360
        • Recruiting
        • University of Pittsburgh
        • Contact:
        • Principal Investigator:
          • Tawfiq Al-lahham, MD
    • Virginia
      • Richmond, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All people living with ALS/MND at participating multidisciplinary ALS/MND clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALS Functional Rating Scale-Revised (ALSFRS-R)
Time Frame: Every 3-4 months up to 5 years

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.
Every 3-4 months up to 5 years
Slow Vital Capacity (SVC)
Time Frame: Every 3-4 months up to 5 years
Slow vital capacity test normalized to age, sex, and height
Every 3-4 months up to 5 years
Survival
Time Frame: Every 3-4 months up to 5 years
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..
Every 3-4 months up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital Signs
Time Frame: Every 3-4 months up to 5 years
Vital Signs (Weight, BP, HR). Both systolic and diastolic pressure are measured.
Every 3-4 months up to 5 years
Neurological Examination
Time Frame: Through study completion, annually up to 5 years
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
Through study completion, annually up to 5 years
El Escorial Criteria
Time Frame: Through study completion, annually up to 5 years
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.
Through study completion, annually up to 5 years
Handheld Dynamometry
Time Frame: Every 3-4 months up to 5 years
Handheld Dynamometry for quantitative strength testing of 18 muscles that is a reliable and reproducible measure of decline in ALS
Every 3-4 months up to 5 years
Grip Strength Testing
Time Frame: Every 3-4 months up to 5 years
Grip Strength Testing
Every 3-4 months up to 5 years
Rasch Overall ALS Disability Scale (ROADS)
Time Frame: Every 3-4 months up to 5 years
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
Every 3-4 months up to 5 years
5 Times Sit to Stand
Time Frame: Every 3-4 months up to 5 years
5 Times Sit to Stand Test
Every 3-4 months up to 5 years
10 Meter Walk Test
Time Frame: Every 3-4 months up to 5 years
10 Meter Walk Test
Every 3-4 months up to 5 years
Physical Examination
Time Frame: Through study completion, annually up to 5 years
Physical Examination that includes the following test areas for abnormality and clinical significance: respiratory, cardio, gastrointestinal, genitourinary. and musculoskeletal
Through study completion, annually up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Northwestern University
University of Pittsburgh
Hadassah Medical Organization
University of Florida
University of Minnesota
Henry Ford Health System
Temple University
Virginia Commonwealth University
Kaiser Permanente
Thomas Jefferson University
Lahey Clinic
Providence Health & Services
Tel Aviv Medical Center
Istituti Clinici Scientifici Maugeri SpA
St. Louis University
Fondazione Serena Onlus - Centro Clinico NeMO Milano
Trinity Health Michigan

Investigators

  • Principal Investigator: Alexander Sherman, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P001670
  • 5U01FD008125-02 (U.S. FDA Grant/Contract: FDA OOPD)
  • 2022A011556 (Other Grant/Funding Number: Biogen, Inc.)
  • 2022A018800 (Other Grant/Funding Number: Mitsubishi Tanabe Pharma America)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

10-30 days from the initial request's online submission

IPD Sharing Access Criteria

ALS/MND Natural History Consortium's Data Access committee reviews the merits of the requestors' research proposals and approves or denies data access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: NeuroGUID/NeuroSTAmP
    Information comments: Anonymized data may be requested by submitting research proposal online. Data Access Committee will review the submission and upon its approval and execution of the Data Sharing Agreement, the dataset will be provided to the data requestor.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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