PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis (PRESS-ALS)

University of Miami

Status: Active, not recruiting

Conditions: Amyotrophic Lateral Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT01508962

PRESS-ALS

Details and patient eligibility

About

The goal of PRESS-ALS is to study the earliest manifestations of disease in people with early ALS in whom some areas of the body are not yet affected.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

ALS group:

• Subject is a male or female, aged at least 18 years.
• Subject is affected with ALS (familial or sporadic).
• Subject has at least one limb in which there is no symptomatic upper and lower motor neuron dysfunction.
• Subject is willing and able to comply with all study procedures.
• Subject agrees to provide signed and dated informed consent form.

Control group:

• Subject is a male or female, aged at least 18 years.
• Subject is not affected with ALS or an ALS-related disorder.
• Subject does not have a family history (i.e., at least 2 biological relatives) of ALS or an ALS-related disorder.
• Subject is willing and able to comply with all study procedures.
• Subject agrees to provide signed and dated informed consent form.

Exclusion Criterion

• Any condition or situation which, in the PI's opinion, could confound the biomarker data or may interfere significantly with the individual's participation and compliance with the study protocol, including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).

Trial design

100 participants in 2 patient groups

Healthy individuals (controls)

Individuals affected with ALS (sporadic or familial)