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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Person living with ALS/MND | An adult over the age of 18, that has received a diagnosis of ALS or other Motor Neuron Disease from a practicing physician. | ||
| Asymptomatic gene carrier | An adult over the age of 18 who does not have symptoms of ALS and carries a mutation known to be associated with ALS | ||
| Healthy Volunteer | An adult over the age of 18 who does not have any biological connection to ALS or other Motor Neuron Disease, and no significant health problems. |
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| Measure | Description | Time Frame |
|---|---|---|
| ALS Functional Rating Scale - Revised (ALSFRS-R) | A questionnaire completed by the participant that assesses 12 daily functions of living on a 0 (severe symptoms) to 4 (minimal to no symptoms) integer scale. | Monthly, through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Machine-Learning Based Speech Scoring | Participants submit a scripted voice recording of 5 different, short phrases that are then scored by a machine-learning based algorithm that assess dysarthria on a non-integer scale of 0 (fully impaired) to 4 (normal speech) | Monthly, through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Participants can be located anywhere but require internet access.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alan S Premasiri, M.S. | Contact | 617-441-7200 | 7291 | apremasiri@als.net |
| Beth Levine | Contact | 617-441-7200 | blevine@als.net |
| Name | Affiliation | Role |
|---|---|---|
| Fernando G Vieira, M.D. | ALS Therapy Development Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALS Therapy Development Institute | Recruiting | Watertown | Massachusetts | 02472 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39707523 | Result | 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. | |
| 37604821 | Result | 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. |
| Label | URL |
|---|---|
| ARC Sign Up Page | View source |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D016472 | Motor Neuron Disease |
| D000386 | AIDS-Related Complex |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
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Fibroblasts, Serum, Plasma, Whole Blood
| Limb-based Accelerometry |
Participants wear four, ActiGraph devices on each limb. Passive and active (video-directed) wear time data is collected over one week. The devices measure acceleration and represent the strength of each limb during movement. Outputs include activity counts and raw acceleration data. |
| monthly, through study completion, an average of 6 months |
| Medications, Supplements, and Clinical Trial Participation Surveys | Participants complete questionnaires describing usage information about medications and supplements they have taken and are currently taking, as well as clinical trial participation. | quarterly, through study completion, an average of 1 year |
| Social and Environmental Surveys | Participants complete questionnaires about their familial, educational, and geographical background, as well as lifestyle habits and past medical conditions and injuries. These are non-current factors that may have an affect on current health outcomes. | One-time or quarterly at months 1, 4, 7, 10 |
| 35396385 | Result | 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. |
| ARC Data Commons Inquiry Page - for researcher access to ARC data | View source |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |