Purpose

The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is being funded by the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases. ASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

for ALS participants: 1. Age 18 years or older 2. Capable of providing informed consent 3. Willing to follow study procedures 4. Diagnosis of ALS by a physician 5. Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient) Inclusion Criteria for control participants: 1. Age 18 years or older 2. Capable of providing informed consent 3. Willing to follow study procedures 4. No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS) 5. No history of familial ALS/Frontotemporal Dementia (FTD) in a close family member** unless the participant has previously tested negative for the known causative ALS genes. Participants with a family history of singleton ALS are permitted to enroll. - ** Defined by the presence of a known ALS causative gene such as C9orf72 in a family member or a family history suggestive of an inherited ALS/FTD syndrome defined by two family members with a history of ALS and/or FTD. 6. Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)

Exclusion Criteria

for all participants: 1. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression <= 90 days of screening, that would interfere with the study procedure, according to Investigator's judgement. 2. Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment. Exclusion Criteria for participants undergoing optional Lumbar Puncture 1. Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure). 2. Allergy to Lidocaine or other local anesthetic agents. 3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture. 4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure. 5. Current pregnancy based on participant self-report 6. Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Symptomatic ALS on-site participants Symptomatic ALS Participants who are completing on-site visits at one of the 35 participating ALL ALS sites.
Symptomatic ALS off-site (remote) participants Symptomatic ALS Participants who are completing visits study visits remotely through video-conferencing. Home Phlebotomy is being used to collect blood from these participants.
Control participants Control participants who do not have a diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS). These participants complete on-site visits.

Recruiting Locations

University of Alabama Birmingham
Birmingham 4049979, Alabama 4829764 35294
Contact:
Melanie Benge
205-975-0445
melaniebenge@uabmc.edu

Barrow Neurological Institute
Phoenix 5308655, Arizona 5551752 85013
Contact:
Christopher Shiver
6024067773
fulton.research@dignityhealth.org

University of California, Irvine
Irvine 5359777, California 5332921 92868
Contact:
Rosa Gonzalez
714-456-6191
rosaig1@hs.uci.edu

University of California San Diego
La Jolla 5363943, California 5332921 98037
Contact:
Gil Gutierrez
858-246-2325
grg005@health.ucsd.edu

University of California, San Francisco
San Francisco 5391959, California 5332921 94143
Contact:
Hannah George
415-353-2959
hannah.george@ucsf.edu

University of Colorado Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
Contact:
Alexis Shepardson
303-724-4644
neuroresearch@cuanschutz.edu

Hospital For Special Care
New Britain 4839292, Connecticut 4831725 06053
Contact:
Sabine Lebel-Hardenac
shardenack@hfsc.org

Georgetown University
Washington D.C. 4140963, District of Columbia 4138106 20007
Contact:
Cassandra Holmes
904-953-3730
cassie.holmes@georgetown.edu

Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224
Contact:
Jany Dagher
904-953-3730
dagher.jany@mayo.edu

Saint Alphonsus Regional Medical Center
Boise 5586437, Idaho 5596512 83704
Contact:
Helena Snider
208-367-7397
neuro.research@saintalphonsus.org

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Aeryn Hopwood
(312) 503-5166
aeryn.hopwood@northwestern.edu

Indiana University
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Lisa Grinstead
317-963-7382
lgrinste@iu.edu

John Hopkins University
Baltimore 4347778, Maryland 4361885 21205
Contact:
Delayne Willie
(410)502-6597
dwillie2@jh.edu

Nih/Ninds
Bethseda, Maryland 4361885 20892
Contact:
Katelyn Porter
301-451-1229
katelyn.porter@nih.gov

Massachusetts General Brigham
Boston 4930956, Massachusetts 6254926 02145
Contact:
Miranda Duncan
(617) 643-9550
mghassessallals@mgb.org

University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Caroline Piecuch
734-936-8781
carolinp@med.umich.edu

Henry Ford Health
Detroit 4990729, Michigan 5001836 48202
Contact:
Maria Stotland
313-916-3359
mstotla1@hfhs.org

University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
Contact:
Julia Munoz
612-624-9989
munoz156@umn.edu

Washington University
St Louis 4407066, Missouri 4398678 63110
Contact:
Jesse Markway
1-844-257-2273
als@wustl.edu

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
Contact:
Nathan McKain
(402) 552-6241
nmckain@unmc.edu

Dartmouth Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756
Contact:
Gina Kersey
603-650-6496
neuroresearch@hitchcock.org

Columbia University
New York 5128581, New York 5128638 10032
Contact:
Ben Hoover
212-305-6788
alsresearch@cumc.columbia.edu

Duke University
Durham 4464368, North Carolina 4482348 27705
Contact:
Duke Research Team
alsresearch@dm.duke.edu

Ohio State University
Colombus, Ohio 5165418 43221
Contact:
Alexander Michael
614-685-4741
alsresearch@osumc.edu

Providence ALS Center
Portland 5746545, Oregon 5744337 97213
Contact:
Kimberly Perry
(971) 231-8245
kimberly.perry2@providence.org

Penn State Health
Hershey 5193342, Pennsylvania 6254927 17033
Contact:
Michele Hare
717-531-8257
nervemuscle@pennstatehealth.psu.edu

Temple University
Philadelphia 4560349, Pennsylvania 6254927 19140
Contact:
John Furey
267-694-0573
tuf40109@temple.edu

Texas Neurology
Dallas 4684888, Texas 4736286 75206
Contact:
Haley Rucker
214-827-3610
hrucker@texasneurology.com

University of Utah
Salt Lake City 5780993, Utah 5549030 84132
Contact:
Scott Redlin
801-581-7437
scott.redlin@utah.edu

Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23298
Contact:
Demetrius Carter
804-655-0691
demetrius.r.carter@vcuhealth.org

University of Washington
Seattle 5809844, Washington 5815135 98195
Contact:
Lila Brisk
(206) 543-0454
lbrisk@uw.edu

CHALS-CCT, University of Puerto Rico, Medical Sciences Campus
San Juan 4568127, Puerto Rico, Puerto Rico 00935
Contact:
Frances M Aponte
734-936-8781
frances.aponte2@upr.edu

More Details

NCT ID
NCT06578195
Status
Recruiting
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix

Study Contact

ALL ALS Patient Navigator
602-845-0248
info@all-als.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.