Fluid Biomarkers with Deep Phenotyping in Patients with ALS

Study Purpose:

The goal of the study is to continue to build the Northeast ALS Consortium (NEALS) biorepository with this collection protocol to associate biofluid collection with specific measures of upper and lower motor neuron function.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Sporadic ALS

Study Type:

Observational Study

Study Category:

Other

Study Status:

Active, currently recruiting

Phase:

Not Applicable

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

Shafeeq Ladha, Barrow Neurological Institute

Clinicaltrials.gov ID (11 digit #):

NCT02819765

Neals Affiliated?

Yes

Coordinating Center Contact Information

Barrow Neurological Institute
Kerisa Shelton, PhD / .(JavaScript must be enabled to view this email address) / 602-406-6598
Alana K Ridge, MPH, CPH / .(JavaScript must be enabled to view this email address) / 602-406-8040
Phoenix, Arizona 85013 United States

Full Study Summary:

The Northeast ALS Consortium (NEALS) biorepository is an existing resource which has provided scientists with a wide range of samples associated with clinical information. Our goal is to continue to build this repository with this collection protocol to associate biofluid collection with specific measures of upper and lower motor neuron function. This project will compliment others to upgrade the NEALS biorepository infrastructure, including updating the computer systems, expanding the number of sample freezers and establishing a repository in the Western United States, and strengthening the standard operating procedures for the repository. The project also supports existing efforts to expand the biorepository by collecting new blood and spinal fluid samples from people with ALS. This is a multicenter, non-interventional, longitudinal study in patients with ALS. There will be four (4) subject visits in this study: Baseline, month 6, month 12, and month 18. At each visit, subjects will have biofluids collected, and be evaluated with assessment tools that focus on upper and lower motor neuron burden as well as cognitive function.

The primary objective of the study is to obtain information on patients studied at regular intervals over 18 months, in conjunction with biofluid collection over that same time period. The secondary objective of the study is to integrate data from this study to other ongoing projects via the NEALS biorepository, and future collections now being planned. The outcome measures of this study are as follows:
• Motor unit number estimation will be performed on bilateral upper extremity muscles using the multipoint incremental technique (MIMNUE)
• Vital capacity, measured using slow vital capacity (SVC)
• Lower motor neuron excitability will be assessed with threshold tracking nerve conduction studies (ttNCS) in the least affected intrinsic hand muscle
• Cognitive abnormalities will be assessed using the ALS Cognitive Behavior Screen (ALS-CBS™)
• Upper motor neuron burden will be assessed using transcranial magnetic stimulation (TMS), employing a paired pulse protocol and recording from the least affected upper extremity intrinsic hand muscle
• Hand held dynamometry (HHD) will be performed on 9 muscle groups tested bilaterally
• Global function (ALSFRS-R)

At each visit, blood will be collected and banked for biomarker discovery; CSF will be collected at baseline, month 6, and at month 18.

Study Sponsor:

The ALS Association and Fulton Family Foundation

Participant Duration:

18 months

Estimated Enrollment:

150

Estimated Study Start Date:

02/07/2017

Estimated Study Completion Date:

07/01/2018

Posting Last Modified Date:

09/26/2017

Date Study Added to alsconsortium.org:

06/06/2016
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    75

    Time since Symptom Onset:

    Time since Diagnosis:

    <24 months

    Can participants use Riluzole?

    Yes


    Expected to survive >1 year (12 months) after enrollment

    Ability to medically undergo lumbar puncture (LP) as determined by the investigator (i.e., no bleeding disorder, allergy to local anesthetics, a skin infection at or near the LP site, or evidence of high intracranial pressure).

    Willingness and medical ability to comply with scheduled visits, LP for CSF collection, laboratory tests, and other study procedures.

    Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.

    Geographic accessibility to the study site.

  • Site Contact Information

    Medical University of South Carolina
    Michelle DeCandio, RN, OCN / .(JavaScript must be enabled to view this email address) / 843-792-9016
    Department of Neurosurgery & Neurology
    Charleston, South Carolina 29425
    United States

    University of Pittsburgh Medical Center
    Monica R Johnson Solomon / .(JavaScript must be enabled to view this email address) / 412-624-9914
    Pittsburgh, Pennsylvania 15213
    United States

    Hospital for Special Surgery (HSS)
    Mona Shahbazi / 212-774-2361
    New York, New York 10021
    United States

    University of Minnesota
    Valerie Ferment / .(JavaScript must be enabled to view this email address) / 612-301-1535
    Department of Neurology
    Minneapolis, Minnesota 55455
    United States

    Spectrum Health
    Brandon James / .(JavaScript must be enabled to view this email address) / 616-486-2058
    Grand Rapids, Michigan 49503
    United States

    University of Michigan
    Jayna Duell, BSN, RN / .(JavaScript must be enabled to view this email address) / 734-763-9037
    Neurology - ALS Clinic
    Ann Arbor, Michigan 48109
    United States

    University of Florida
    Rhonda Calhoun, RN, BSN / .(JavaScript must be enabled to view this email address) / 904-244-9856
    Department of Neurology
    Jacksonville, Florida 32209
    United States

    University of California, Irvine
    Marie Wencel, CCRP / .(JavaScript must be enabled to view this email address) / 714-456-2525
    Dept. of Neurology
    Orange, California 92868
    United States

    Barrow Neurological Institute
    Nicole Turcotte / .(JavaScript must be enabled to view this email address) / 602-406-4775
    Phoenix, Arizona 85013
    United States

    Georgia Regents University
    Brandy Quarles / .(JavaScript must be enabled to view this email address) / 706-721-2681
    Nicole Smalley / .(JavaScript must be enabled to view this email address) / Agusta, Georgia 30912
    United States

    Las Vegas Clinic
    Kaitlyn McKenna / .(JavaScript must be enabled to view this email address) / 702-505-4230
    Las Vegas, Nevada 89145
    United States

    University of Nevada
    Amrita Patel / .(JavaScript must be enabled to view this email address) / 702-671-5093
    Las Vegas, Nevada 89102
    United States

    Columbia University Medical Center
    Jessica Singleton / .(JavaScript must be enabled to view this email address) / 212-305-7221
    New York, New York 10032
    United States

    University of Pittsburgh Medical Center
    Monica R Johnson Solomon / .(JavaScript must be enabled to view this email address) / 412-624-9914
    Danielle Rowlands / .(JavaScript must be enabled to view this email address) / 412-864-2873
    Pittsburgh, Pennsylvania 15213
    United States