ALS Clinical Trial
Official title:
ALS/MND Natural History Study Data Repository
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Centro Clinico NEMO Milano | Milan | |
United States | Northwestern University | Chicago | Illinois |
United States | Henry Ford Health System | Detroit | Michigan |
United States | University of Florida | Gainesville | Florida |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Temple University Lewis Katz School of Medicine | Philadelphia | Pennsylvania |
United States | Providence ALS Clinic | Portland | Oregon |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Saint Louis University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Fondazione Serena Onlus - Centro Clinico NeMO Milano, Henry Ford Health System, Northwestern University, Providence Health & Services, St. Louis University, Temple University, University of Florida, University of Minnesota, Virginia Commonwealth University |
United States, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ALS Functional Rating Scale-Revised (ALSFRS-R) | 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 | |
Primary | Slow Vital Capacity (SVC) | Slow vital capacity test normalized to age, sex, and height | Every 3-4 months up to 5 years | |
Primary | Survival | 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 | Vital Signs | Vital Signs (Weight, BP, HR). Both systolic and diastolic pressure are measured. | Every 3-4 months up to 5 years | |
Secondary | Neurological Examination | 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 | |
Secondary | El Escorial Criteria | 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 | |
Secondary | Handheld Dynamometry | 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 | |
Secondary | Grip Strength Testing | Grip Strength Testing | Every 3-4 months up to 5 years | |
Secondary | Rasch Overall ALS Disability Scale (ROADS) | 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 | |
Secondary | 5 Times Sit to Stand | 5 Times Sit to Stand Test | Every 3-4 months up to 5 years | |
Secondary | 10 Meter Walk Test | 10 Meter Walk Test | Every 3-4 months up to 5 years | |
Secondary | Physical Examination | 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 |
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