Study Aims
Natural History Dataset:
- Made available to academic and industry investigators to advance ALS care, drug development, and outcomes research.
Blood Collection:
- Testing of exploratory biomarkers
- Whole Genome Sequencing (performed at the American Genome Center of the Uniformed Services University)
- Plasma, serum, and PBMC biorepository at the University of Minnesota
- Time-to-event disease progression modeling
Study Protocol
This is a clinic-based natural history study and registry. Once the participant enrolls in the study at the clinic all data collection will occur remotely. At this point in time, we are only able to enroll patients who are currently being served by the Consortium ALS Clinics. Biospecimen (e.g. blood) collection will be done at the ALS Clinic in alignment with the participant's care schedule.
Summary of Assessments for Participants | Enrollment Visit | Follow Up Visit |
| Informed Consent | X | |
ALS/MND History | ||
| ALS/MND History: date of first symptom, diagnosis date, site of onset | X | |
MND Phenotype:
| X | X |
| Cognitive Phenotype: ALS behavioral impairment (ALSbi), ALS cognitive impairment (ALSci), ALS combined cognitive and behavioral impairment (ALScbi), ALS with frontotemporal dementia (ALS-FTD) | X | X |
| Other neurological symptoms: sensory, autonomic, other | X | X |
| Diagnostic Criteria | X | |
| Family History: MND, dementia, other | X | |
| Genotype: positive, negative, laboratory used | X | |
| Demographics: DOB, Sex assigned at birth, race/ethnicity, Socioeconomic status, Educational level, Occupation, Military status, History of athletic participation, Head injuary history | X | |
| Medical Comorbidities | X | X |
| Past Surgical History | X | |
| Interim Events: Hospitalizations, Falls, Infections, Thromboses, Power wheelchair, Noninvasive ventilator (NIV) initiation, Gastrostomy placement, Hospice referral, NIV use >22 hours, Tracheostomy, Death | X | |
Clinical Procedures and Assessments | ||
| Vital Signs: weight (kg), calculated BMI | X | X |
| Medical Examination | X | X |
| ALSFRS-R (ALS Participants) | X | X |
| 10-meter walk test | X | X |
| Speaking rate | X | X |
| PLSFRS (PLS Participants) | X | X |
| Rasch-built Overall ALS Disability Scale (ROADS) | optional | optional |
| ALS Cognitive Behavioral Screen (ALS-CBS) | X | |
| Pulmonary Testing: Upright forced vital capacity | X | X |
| Other Testing: Supine testing, MIP, MEP, peak cough flow | optional | optional |
| Biofluid Collection (e.g. blood) | X | X |