Amyotrophic Lateral Sclerosis

Data Standards

Organized by domains and subdomains often used in clinical studies, data standards include:

•         CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory

•         CRF Modules — Template forms that logically organize CDEs for data collection

•         Guidance Documents — Provide further information about the CDEs

•         Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)

Amyotrophic Lateral Sclerosis Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Amyotrophic Lateral Sclerosis study start-up

Amyotrophic Lateral Sclerosis Highlight Summary: Overview of all Amyotrophic Lateral Sclerosis-specific CDE recommendations as they appear on the website

Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.

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NIH Resources
NIH Resources
CRF Module/Guidance CDEs
National Institutes of Health (NIH) Toolbox N/A
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Participant Characteristics
Demographics
CRF Module/Guidance CDEs
Demographics CDE Details
General Core CDE Details
Social Status
CRF Module/Guidance CDEs
Social Status CDE Details
Participant History and Family History
General Health History
CRF Module/Guidance CDEs
Family History CDE Details
Medical History CDE Details
Disease/Injury Related Events
Classification
CRF Module/Guidance CDEs
Symptom, Sign, Diagnosis Criteria CDE Details
Genetics CDE Details
Assessments and Examinations
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
Biomarkers Other Collection Information Guidelines N/A
Collection of Fluid: Blood Guidelines N/A
Collection of Fluid: CSF Guidelines N/A
Collection of Fluid: Plasma Guidelines N/A
Collection of Fluid: Urine Guidelines N/A
Fasting Information CDE Details
Laboratory Tests CDE Details
Resting Energy Expenditure CDE Details
Tissue Based Marker Collection CDE Details
Imaging Diagnostics
CRF Module/Guidance CDEs
Brain Perfusion Magnetic Resonance Imaging CDE Details
Diffusion Tensor Imaging (DTI) CDE Details
Functional Magnetic Resonance Imaging (fMRI) CDE Details
Magnetic Resonance Imaging (MRI) CDE Details
Magnetic Resonance Spectroscopy CDE Details
Non-Imaging Diagnostics
CRF Module/Guidance CDEs
Electrophysiology CDE Details
Physical/Neurological Examination
CRF Module/Guidance CDEs
Neuromuscular Examination CDE Details
Physical Examination CDE Details
Vital Signs and Other Body Measures
CRF Module/Guidance CDEs
Vital Signs CDE Details
Treatment/Intervention Data
Drugs
CRF Module/Guidance CDEs
Prior and Concomitant Medications CDE Details
Outcomes and End Points
Muscle Strength Testing
CRF Module/Guidance CDEs
Pinch Strength N/A
Fixed Dynamometry CDE Details
Grip Strength CDE Details
Grip Strength Fatigue CDE Details
Hand Held Dynamometry CDE Details
Manual Muscle Testing-Using the Medical Research Council Muscle Grading Scale CDE Details
Cognitive
CRF Module/Guidance CDEs
Cognitive Recommendations Guidelines for Use N/A
ALS Cognitive Behavioral Screen N/A
ALS Depression Inventory (ADI-12) N/A
Amyotrophic Lateral Sclerosis-Frontotemporal Dementia-Questionnaire (ALS-FTD-Q) N/A
Beck Depression Inventory II (BDI-II) N/A
Cambridge Behavioral Inventory - Revised N/A
Center for Neurologic Study - Lability Scale for pseudobulbar affect (PBA) N/A
Edinburgh Cognitive Behavioral ALS Screen (ECAS) N/A
Emotional Lability Questionnaire: Person with MND (ELQ-MND) N/A
Emotional Lability Questionnaire: Relatives and Carers (ELQ-R and C) N/A
Frontal Behavioral Inventory (FBI) N/A
Frontal Behavioral Inventory - ALS Version (FBI-ALS) N/A
Frontal Behavioral Inventory - Modified by Heidler Gary N/A
Frontal Systems Behavioral Scale (FrSBe) N/A
Geriatric Depression Scale (GDS) CDE Details
Hamilton Depression Rating Scale (HDRS) CDE Details
Hospital Anxiety and Depression Scale (HADS) N/A
Motor Neuron Disease Behavioural Instrument (MiND-B) N/A
Neuropsychiatric Inventory - Clinician Version (NPI-C) N/A
Neuropsychiatric Inventory Questionnaire (NPI-Q) N/A
Penn State Screen of Frontal and Temporal Dysfunction Syndromes N/A
UCSF Screening Exam N/A
Written Verbal Fluency Test N/A
Functional Outcomes
CRF Module/Guidance CDEs
6 Minute Walk Test N/A
ALS Functional Rating Scale - Revised (ALSFRS-R) N/A
ALS Swallowing Severity Scale (ALSSS) N/A
Barthel Index N/A
Center for Neurologic Study - Bulbar Function Scale (CNS-BFS) N/A
Checklist for Individual Strength - Fatigue (CIS) N/A
Clinical Milestones/Events CDE Details
Death Report N/A
Dynamic Gait Index (DGI) CDE Details
Edmonton Symptom Assessment System (ESAS) N/A
EuroQoL-5 Dimension Questionnaire (EQ-5D) N/A
Fatigue Severity Scale (FSS) CDE Details
Madrid Quantitative Neuromuscular Assessment (MAQUINA) N/A
Modified Fatigue Impact Scale (MFIS) CDE Details
Performance-Oriented Mobility Assessment (POMA) N/A
Schwab and England Activities of Daily Living Scale (ADL-Scale) CDE Details
Sensory Organization Test (SOT) N/A
Timed 25-Foot Walk (T25-FW) CDE Details
Timed Up and Go (TUG) N/A
Summary of All Outcome Recommendations
CRF Module/Guidance CDEs
ALS CDE Instrument Recommendations by Outcome Domain and Classification N/A
ALS Outcomes Recommendations Guidelines for Use N/A
Quality of Life/Patient Reported Outcomes
CRF Module/Guidance CDEs
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) N/A
EuroQoL-VAS N/A
McGill Quality of Life Questionnaire (MQOL) N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Quality of Life in Swallowing Disorders (SWAL-QOL) N/A
Schedule for the Evaluation of Individual Quality of Life - Direct Weighting (SEIQoL-DW) N/A
Short Form 36-Item Health Survey (SF-36) N/A
Sickness Impact Profile (SIP) N/A
Pulmonary Function Testing/Respiratory Status
CRF Module/Guidance CDEs
Baseline Dyspnea Index (BDI) N/A
Borg Dyspnea Scale N/A
Myocardial Oxygen Consumption, Gas Exchange and Nocturnal Oximetry CDE Details
Pulmonary Function CDE Details
Transition Dyspnea Index (TDI) N/A
Subjective Assessments/Patient and Caregiver Reported Outcomes
CRF Module/Guidance CDEs
Caregiver Burden Scale (CGBS) N/A
Clinical Global Impression Scale N/A
Zarit Burden Interview (ZBI) N/A
Upper Motor Neuron Signs/Neuromuscular Excitability
CRF Module/Guidance CDEs
Modified Ashworth Scale for Grading Spasticity N/A
NINDS Myotatic Reflex Scale N/A
Tardieu Scale CDE Details

Prospective Assessments for Suicidal Ideation and Behavior

Investigators should review the FDA’s "Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials” for the most up-to-date information about suicidal ideation and behavior. One scale that FDA suggests is the Columbia Suicide Severity Rating Scale (C-SSRS) (available at https://cssrs.columbia.edu/).

Instrument Notice of Copyright Information

The NINDS CDE Team does not post proprietary instruments/scales recommended by the CDE Working Groups on this website. This includes, but is not limited to, copyrighted or trademarked instruments/scales. Information about recommended instruments can be found in the Notice of Copyright (NOC) documents under ‘CRF Module/Guidance’ on each disorder’s data standards page. For any questions regarding these instruments/scales please contact the corresponding owner/author. The NINDS CDE Team is not responsible for the availability or content of these external sites, nor does the NINDS CDE Team endorse, warrant or guarantee the products, services or information described or offered at these other internet sites.

Overview

The first set of Common Data Elements (CDEs) for Amyotrophic Lateral Sclerosis was developed in 2011.

To develop the Amyotrophic Lateral Sclerosis (ALS) CDEs, the ALS CDE Working Group divided into subgroups to focus on identifying and defining data elements in the domains of:

  • Biomarkers and Imaging
  • Clinical Research/ Quality of Life
  • Cognitive/ Frontotemporal Dementia
  • Genetics

Roster

The National Institute of Neurological Disorders and Stroke (NINDS) has formed an Oversight Committee to direct the updating and further development of Amyotrophic Lateral Sclerosis CDEs. The Amyotrophic Lateral Sclerosis CDE Committee is supported by the NINDS CDE Team.

Previously, the Amyotrophic Lateral Sclerosis CDE Committee was currently comprised of four different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups.

The Working Group members served on either one or two subgroups. The subgroups began meeting by teleconference in November 2010 and continued to hold calls every four to six weeks through spring 2011 to define the CDEs for their domains and to recommend standardized, validated instruments for ALS research. The Amyotrophic Lateral Sclerosis CDE Oversight Committee was created in 2013.

Complete Amyotrophic Lateral Sclerosis CDE Roster

Oversight Committee Members

Oversight Committee Members

  • Edward Kasarskis, MD, PhD
    University of Kentucky College of Medicine, Veterans Affairs Medical Center, Lexington, Kentucky
    Chair
  • James D. Berry, MD, MPH
    Massachusetts General Hospital, Boston, Massachusetts
  • Adriano Chio, MD
    University of Torino, AOU San Giovanni Battista, Turin, Italy
  • Omar Jawdat, MD
    University of Kansas Medical Center, Kansas City, Kansas
  • Prof. Dr. Med. Albert Ludolph
    Universitats - und Rehabilitationskliniken Ulm, Ulm, Germany
  • Alex Sherman, MS
    Neurological Clinical Research Institute, Massachusetts General Hospital, Boston, Massachusetts
  • Bryan Traynor, MB, MD, PhD, MMSc, MRCPI
    National Institute on Aging (NIA), National Institutes of Health (NIH), Bethesda, Maryland
  • Susan Woolley-Levine, PhD
    Sutter Pacific Medical Center, San Francisco, California
  • Sharon Abrahams, PhD
    University of Edinburgh, Edinburgh, Scotland, United Kingdom
  • Christina Fournier, MD, MSc
    Emory University, Atlanta, Georgia
  • Timothy Fullam, MD
    Brooke Army Medical Center, San Antonio, Texas
  • Mark Garret, MD
    Mass General Research Institute, Massachusetts General Hospital, Boston Massachusetts
  • Collin Hovinga, PharmD, MS, FCCP
    Critical Path Institute, Tucson, Arizona

Previous ALS Oversight Committee Members

Previous ALS Oversight Committee Members

  • Christin Bermudez Andrews, PhD
    University of Miami, Miami, Florida
  • Lucie Bruijn, PhD, MBA
    Dementia Discovery Fund, Boston, Massachusetts
  • Valerie Cwik, MD
    Muscular Dystrophy Association, Tucson, Arizona
  • Murray Grossman, MD, EdD
    University of Pennsylvania, Philadelphia, Pennsylvania
  • Amanda Haidet-Phillips, PhD
    AveXis, Bannockburn, Illinois
  • Melanie Leitner, PhD (Until 2024)
    Accelerating NeuroVentures, LLC, Boston, Massachusetts
  • Jennifer Murphy, PhD (Until 2024)
    University of California San Francisco, San Francisco, California (Ad Hoc Member)
  • Martin Turner, PhD
    Oxford University, Oxford, United Kingdom

Working Group Co-Chairs

Working Group Co-Chairs

  • Lucie Bruijn, PhD
    ALS Association, Washington, District of Columbia
  • James Caress, MD
    Wake Forest University, Winston-Salem, North Carolina

Biomarkers/ Imaging

Biomarkers/ Imaging

  • Robert Bowser, PhD
    Barrow Neurological Institute, Phoenix, Arizona
    Chair
  • Michael Benatar, MS, DPhil
    University of Miami School of Medicine, Miami, Florida
  • Jonathan Glass, MD
    Emory University School of Medicine, Atlanta, Georgia
  • Varan Govind, PhD
    University of Miami School of Medicine, Miami, Florida
  • Vincent Meininger, MD, PhD
    Federation des Maladies du Systeme Nerveux, Hopital de la Salpetriere, Paris, France
  • Hiroshi Mitsumoto, MD
    Columbia University Motor Neuron Center, New York, New York
  • Jeremy Shefner, MD, PhD
    Upstate Medical University, Syracuse, New York
  • Alexander Sherman, MD
    Massachusetts General Hospital, Boston, Massachussetts
  • Martin Turner, PhD
    Oxford University, Oxford, United Kingdom

Clinical Research/ Quality of Life (QOL)

Clinical Research/ Quality of Life (QOL)

  • Merit Cudkowicz, MD, MSc
    Massachusetts General Hospital, Boston, Massachusetts
    Chair
  • Stanley Appel, MD
    Houston Methodist Hospital, Houston, Texas
  • Richard Barohn, MD
    University of Kansas Medical Center, Kansas City, Kansas
  • Michael Benatar, MS, DPhil
    University of Miami School of Medicine, Miami, Florida
  • Frank Bennett, PhD
    Ionis Pharmaceuticals, Carlsbad, California
  • Kathie Bishop, PhD
    Tioga Pharmaceuticals, San Diego, California
  • Benjamin Rix Brooks, MD
    Carolinas Healthcare System, Charlotte, North Carolina
  • Jesse Cedarbaum, MD
    Bristol-Myers Squibb, New York City, New York
  • Valerie Cwik, MD
    Muscular Dystrophy Association, Tucson, Arizona
  • Julaine Florence, PT, MHS, DPT
    Washington University School of Medicine, St. Louis, Missouri
  • Orla Hardiman, MD
    Trinity College Institute of Neuroscience, Dublin, Ireland
  • Laura Herbelin, CCRP
    University of Kansas Medical Center, Kansas City, Kansas
  • Edward Kasarskis, MD, PhD
    University of Kentucky College of Medicine, Lexington, Kentucky
  • Wendy King, PT
    Ohio State University, Columbus, Ohio
  • Zachary Simmons, MD
    Penn State Hershey Medical Center, Hershey, Pennsylvania
  • Richard Smith, MD
    University of California San Diego, Center for Neurological Study, San Diego, California
  • Eric Sorensen, MD
    Mayo Clinical Rochester, Great Lakes ALS, Rochester, Minnesotta
  • Hong Yu, MPH
    Massachusetts General Hospital, Boston, Massachusetts

Cognitive/ Frontotemporal Dementia (FTD)

Cognitive/ Frontotemporal Dementia (FTD)

  • Catherine Lomen-Hoerth, MD, PhD
    University of California San Francisco, San Francisco, California
    Co-Chair
  • Zachary Simmons, MD
    Penn State Hershey Medical Center, Hershey, Pennsylvania
    Co-Chair
  • Sharon Abrahams, PhD
    University of Edinburgh, Edinburgh, United Kingdom
  • Richard Buchsbaum
    Columbia University Mailman School of Public Health, New York City, New York
  • Lora Clawson, MSN, CRNP
    Johns Hopkins Medicine, Baltimore, Maryland
  • Laura Goldstein, PhD
    King's College London, London, United Kingdom
  • Murray Grossman, MD, EdD
    University of Pennsylvania, Philadelphia, Pennsylvania
  • Dan Moore, PhD
    Univeristy of California San Francisco, California Pacific Medical Center, San Francisco, California
  • Jennifer Murphy, PhD
    University of Califonia San Francisco, San Francisco, California
  • Seamus Thompson, PhD
    Columbia University Mailman School of Public Health, New York, New York
  • Susan Woolley, PhD
    Forbes Norris ALS Research Center, San Francisco, California

Genetics

Genetics

  • Bryan Traynor, MB, MD, PhD, MMSc, MRCPI
    National Institute on Aging (NIA), National Institutes of Health (NIH), Bethesda, Maryland
    Chair
  • Robert Brown, MD
    University of Massachusetts Medical School, Worcester, Massachusetts
  • Adriano Chio, MD
    University of Torino, AOU San Giovanni Battista, Torino, Italy
  • Vivian Drory, MD
    Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel
  • Karen Morrison, PhD
    University of Birmingham, Birmingham, United Kingdom
  • Rosa Rademakers, PhD
    Mayo Clinic College of Medicine, Rochester, Minnesotta
  • Kevin Talbot, MD, DPhil
    Oxford University, Oxford, United Kingdom
  • Leonard van den Berg, MD, PhD
    University Medical Center Urecht, Utrecht, Netherlands

NINDS CDE Team

NINDS CDE Team

  • Robin Conwit, MD (Until 2022)
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Amelie Gubitz, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Program Director, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i Hansen, MS (Until 2018)
    The Emmes Company, LLC, Rockville, Maryland
  • Jennifer Clerie, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Robin Feldman, BS, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Aria Lans, MPH
    The Emmes Company, LLC, Rockville, Maryland
  • Amanda Suller, BS (Until 2015)
    The Emmes Company, LLC, Rockville, Maryland
  • Amy Y. Tsou, MD, MSc
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Lisa Hunegs, MSW, MPH (Until 2012)
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Kristy Miller, MPH (Until 2012)
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland
  • Megan Schmidt (Until 2012)
    KAI Research, Inc. (An Altarum Company), Rockville, Maryland

Updates

Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.

Amyotrophic Lateral Sclerosis CDE Revision History