Amyotrophic Lateral Sclerosis (ALS) Tissue Donation Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Drexel University
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Christine Barr, Drexel University Identifier:
First received: July 14, 2008
Last updated: September 18, 2015
Last verified: May 2014

Despite significant progress in the identification of mechanisms involved in motor neuron degeneration in Amyotrophic Lateral Sclerosis (ALS) and other motor system diseases, the actual pathogenesis and cause of these diseases remains unknown. Effective treatment of these diseases are dependent on the elucidation of their causes. The availability of diseased and control human tissues will be a critical resource for this research progress. . Samples of serum, spinal fluid, and urine from patients with motor system diseases can be used to study biochemical and genetic differences compared to tissues of neurologic disease controls and normal controls. Furthermore, the availability of autopsied CNS, PNS, as well as other tissues from patients with ALS or suspected ALS are useful for current and future research studies into the disease. Therefore, we propose to institute a Tissue Bank containing blood, urine, and cerebrospinal fluid donated from not only ALS and other motor neuron disease patients, but also those with other neurologic diseases and normals whose tissue can be used as controls. In addition there will be an autopsy band for post-mortem specimens of ALS and other motor neuron disease patients. Each specimen, whether from a living patient or autopsy will be de-identified and accompanied by a standard set of clinical information collected from the medical records in order that each specimen is characterized with the relevant clinical information to maximize the usefulness of the specimens.

Once established, this tissue bank will provide a resource in which a large number of samples will be readily available and expedite research by circumventing the delays in collecting specimens prospectively. These specimens will be used for research in the ALS Center of Hope at Drexel University College of Medicine and shared with any outside investigator with a valid IRB approved protocol.

Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: ALS Tissue Donation Program

Resource links provided by NLM:

Further study details as provided by Drexel University:

Primary Outcome Measures:
  • None Specified [ Time Frame: None Specified ] [ Designated as safety issue: No ]
    No primary outcome measure is specified for this study. Purpose of the study is to collect deidentified biological specimens which will be used to expedite other IRB approved studies.

Biospecimen Retention:   Samples With DNA
Blood (Serum and DNA) Urine (Serum and DNA) CSF Blood specimens and tissue specimens (from brain, spinal cord, gastrointestinal tract, skeletal muscle and peripheral nerve)

Estimated Enrollment: 300
Study Start Date: April 2007
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Diagnosed with ALS or other motor system disorder including PLS, Bulbar Palsy or Motor neuropathy
Diagnosed with other chronic neurologic illnesses (Alzheimers, multiple sclerosis, migraines, etc)
Normal Controls


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ALS clinic patients at MDA/ALS Center of Hope, along with families and caregivers. Also those with ALS who have donated their bodies to research.

Inclusion Criteria:

  • Diagnosed with ALS or other motor system disorder including PLS, Bulbar Palsy or Motor neuropathy
  • Diagnosed with other chronic neurologic illnesses (Alzheimers, multiple sclerosis, migraines, etc)
  • Normal Controls
  • In the case of spinal fluid collection, the patient will be undergoing a diagnostic lumbar puncture as part of the work-up

Exclusion Criteria:

  • Any person with a non-neurologic chronic and poorly controlled systemic illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00716131

Contact: Christine P Barr, RN 215-762-5186

United States, Pennsylvania
MDA/ALS Center of Hope Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Christine Barr, RN    215-762-5186   
Principal Investigator: Terry Heiman-Patterson, MD         
Sponsors and Collaborators
Drexel University College of Medicine
MDA/ALS Center of Hope
Principal Investigator: Terry D Heiman-Patterson, MD Drexel University College of Medicine
  More Information

Responsible Party: Christine Barr, Research Nurse Coordinator, Drexel University Identifier: NCT00716131     History of Changes
Other Study ID Numbers: Internal-16827 
Study First Received: July 14, 2008
Last Updated: September 18, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
Amyotrophic Lateral Sclerosis
Cerebrospinal Fluid
Neurodegenerative Disease
Motor Neuron Disease
Autonomic Nervous System
Neurodegenerative Diseases
Movement Disorders

Additional relevant MeSH terms:
Motor Neuron Disease
Neurodegenerative Diseases
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Pathologic Processes
Proteostasis Deficiencies
TDP-43 Proteinopathies processed this record on May 25, 2016