ALS (Amyotrophic Lateral Sclerosis), ALS With Frontotemporal Dementia (ALS/FTD), Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Conditions
Keywords
ARC, ALS Research Collaborative, ALS TDI, ALS Therapy Develeopment Institute
Brief summary
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.
Interventions
None listed
Sponsors
ALS Therapy Development Institute
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALS Functional Rating Scale - Revised (ALSFRS-R) | Monthly, through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Machine-Learning Based Speech Scoring | Monthly, through study completion, an average of 1 year | 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) |
| Limb-based Accelerometry | monthly, through study completion, an average of 6 months | 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. |
| Medications, Supplements, and Clinical Trial Participation Surveys | quarterly, through study completion, an average of 1 year | Participants complete questionnaires describing usage information about medications and supplements they have taken and are currently taking, as well as clinical trial participation. |
| Social and Environmental Surveys | One-time or quarterly at months 1, 4, 7, 10 | 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. |
Countries
United States
Contacts
Primary ContactAlan S Premasiri, M.S.
Backup ContactBeth Levine
Outcome results
None listed