Establishment of a Tissue Bank (Blood, CSF) for the Understanding of the Disease Progression and Early Diagnosis of Motor Neuron Disease (MND).

Study Purpose:

Biomarkers are essential for the identification of disease states. There are no early diagnostic or prognostic markers for ALS. The purpose of this study is to identify a panel of biomarkers from blood or spinal fluid of ALS patients and to collect data to better understand disease progression.

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:






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

Benjamin R Brooks, MD, Neurosciences Institute, Neurology - Charlotte ID:


Neals Affiliated?


Coordinating Center Contact Information

Carolinas Medical Center - Dept of Neurology

Charlotte, North Carolina, 28207 United States

Full Study Summary:

Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by progressive degeneration of motor neurons, muscle atrophy and paralysis. There is no reliable early diagnostic test for ALS making identification of the disease difficult at its earliest stages. Early detection is critical to the initiation of early neuroprotective therapy. By the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle has already occurred. The purpose of the current project is to establish a bank of blood samples (serum and protein/RNA/DNA from blood cells) and CSF for use in the development of an early diagnostic test for ALS and to better understand the progression of this disease.

Samples from patients that have a confirmed or unknown diagnosis of motor neuron disease will be examined. ALS and suspected neuromuscular disease (control) samples will be collected for comparison. Investigators will examine various biochemical, metabolic and genetic markers from these samples in hopes of finding differences in the expression between control subjects and ALS patients and how these biomarkers vary during disease progression. Participants will be asked to complete an optional questionnaire to collect data including medication and vitamin use and medical and disease history. This data will be linked to the patient's samples; however, all samples will be deidentified and coded to avoid the possibility of linking results to the patient. Results will not be stored in the patient's medical record.

Study Sponsor:

Wake Forest University Health Sciences

Estimated Enrollment:


Estimated Study Start Date:

03 / 29 / 2004

Estimated Study Completion Date:

10 / 29 / 2020

Posting Last Modified Date:

07 / 11 / 2022

Date Study Added to

09 / 26 / 2013

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years. For more information, visit: https://clinicalt...CT01950910&rank=1

Minimum Age:

18 Years

Maximum Age:


Inclusion Criteria:

- 18 years old or older

Exclusion Criteria:

- less than 18 years old

Neurosciences Institute, Neurology - Charlotte

Charlotte, North Carolina 28207
United States