ALS Research Collaborative
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis, ALS (Amyotrophic Lateral Sclerosis), ALS With Frontotemporal Dementia (ALS/FTD), Motor Neuron Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ALS Translational Research Program
Overview
The goal of this natural history study is to learn more about the biological and clinical aspects of amyotrophic lateral sclerosis (ALS). This study's findings will help with drug discovery, biomarker discovery, and outcome measure validation. Adults living with ALS, other motor neuron diseases (MND), a known mutation related to ALS and healthy volunteers contribute prospective and retrospective data to this study remotely. The study is sponsored and conducted by the ALS Therapy Development Institute.
Primary outcome measures
- ALS Functional Rating Scale - Revised (ALSFRS-R) [Time frame: Monthly, through study completion, an average of 1 year]
Secondary outcome measures (4)
- Machine-Learning Based Speech Scoring [Time frame: Monthly, through study completion, an average of 1 year]
- Limb-based Accelerometry [Time frame: monthly, through study completion, an average of 6 months]
- Medications, Supplements, and Clinical Trial Participation Surveys [Time frame: quarterly, through study completion, an average of 1 year]
- Social and Environmental Surveys [Time frame: One-time or quarterly at months 1, 4, 7, 10]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
- Can communicate in written English
- Has a diagnosis of ALS/MND or is a known carrier of an ALS associated mutation
Exclusion criteria
- Significant cognitive impairment that would prevent individual completion and understanding of the informed consent process.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- ALS Therapy Development Institute — Watertown
Publications
- Straczkiewicz M, Burke KM, Calcagno N, Premasiri A, Vieira FG, Onnela JP, Berry JD. Free-living monitoring of ALS progression in upper limbs using wearable accelerometers. J Neuroeng Rehabil. 2024 Dec 21;21(1):223. doi: 10.1186/s12984-024-01514-7. PMID 39707523
- Gupta AS, Patel S, Premasiri A, Vieira F. At-home wearables and machine learning sensitively capture disease progression in amyotrophic lateral sclerosis. Nat Commun. 2023 Aug 21;14(1):5080. doi: 10.1038/s41467-023-40917-3. PMID 37604821
- Vieira FG, Venugopalan S, Premasiri AS, McNally M, Jansen A, McCloskey K, Brenner MP, Perrin S. A machine-learning based objective measure for ALS disease severity. NPJ Digit Med. 2022 Apr 8;5(1):45. doi: 10.1038/s41746-022-00588-8. PMID 35396385
Identifiers
NCT: NCT06885918 · ALSTDI0103