PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis

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Study Purpose:

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.

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

N/A

Clinicaltrials.gov ID:

NCT01508962

Neals Affiliated?

No

Coordinating Center Contact Information

University of Miami

Miami, Florida, 33136 United States

Full Study Summary:

The goal of TRACK-ALS is to systematically study the onset and progression of ALS.

Study Sponsor:

University of Miami

Estimated Enrollment:

100

Estimated Study Start Date:

10 / 31 / 2013

Estimated Study Completion Date:

12 / 01 / 2027

Posting Last Modified Date:

03 / 10 / 2023

Date Study Added to neals.org:

01 / 12 / 2012

Minimum Age:

18 Years

Maximum Age:

N/A

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).

University of Miami

Miami, Florida 33136
United States