Fluid Biomarkers with Deep Phenotyping in Patients with ALS (ALSA-BIO3)
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 ALSStudy Type:
Observational StudyStudy Category:
biological samplesStudy Status:
EnrollingPhase:
Not ApplicableStudy Chair(s)/Principal Investigator(s):
Shafeeq Ladha, Barrow Neurological Institute
Clinicaltrials.gov ID (11 digit #):
NCT02819765Neals Affiliated?
YesCoordinating Center Contact Information
Barrow Neurological InstituteMeghan Hall / .(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) 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 FoundationParticipant Duration:
4 visits over 18 months