A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Massachusetts General Hospital
ALS Association
ALS Finding a Cure
Information provided by (Responsible Party):
James D. Berry MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
First received: December 16, 2011
Last updated: September 18, 2015
Last verified: September 2015

December 16, 2011
September 18, 2015
November 2011
December 2016   (final data collection date for primary outcome measure)
  • ALS Functional Rating Scale [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]
    The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.
  • Vital Capacity (VC) [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]
    The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal.
  • Hand Held Dynamometry (HHD) [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]
    Hand Held Dynamometry (HHD) will be used as a quantitative measure of muscle strength for this study. Six proximal muscle groups will be examined bilaterally in both upper and lower extremities (shoulder flexion, elbow flexion, elbow extension, hip flexion, knee flexion, and knee extension), all of which have been validated against maximum voluntary isometric contraction (MVIC) testing.
  • Ashworth Spasticity Scale [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]
    This is a standard measure for spasticity, has been used in a previous ALS clinical trials, and is applied in the current trial to evaluate the progression of spasticity due to upper motor neuron dysfunction in ALS.
  • Fronto-Temporal Dementia (FTD) Assessment [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]
    The FTD Screening Assessment is a quickly administered scale used to evaluate memory, executive functions, and language. It is aimed at determining the presence of subtle dysfunction of these domains of cognition and behavior that may portend the onset of FTD or FTD-like symptoms.
  • ALS Cognitive Behavioral Screen (ALS CBS) [ Time Frame: Approximately every 4 months ] [ Designated as safety issue: No ]

    The ALS Cognitive Behavioral Screen (ALS-CBS™) is a short measure of cognition and behavior in patients with Amyotrophic Lateral Sclerosis (ALS). The cognitive section includes commonly used elements of standard testing batteries, consisting of 8 tasks, with a possible total score of 20. It can be administered by a physician or other clinical care staff and takes approximately 5 minutes to complete.

    The behavioral section (ALS Caregiver Behavioral Questionnaire) is composed of questions sensitive to organic brain changes. It consists of a set of questions that compare changes in personality and behavior since the onset of ALS, as well as yes/no questions about mood, pseudobulbar affect, and fatigue. It is completed by a caregiver, family member or other informant during the same time that the patient completes the cognitive portion. The questionnaire typically takes about 2 minutes to complete.

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Complete list of historical versions of study NCT01495390 on ClinicalTrials.gov Archive Site
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A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers
A Multicenter Study for the Discovery and Validation of ALS Biomarkers

The purpose of this study is to collect biofluid samples for the banking and usage in ALS research. Through comparison of these samples, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to develop new therapies.

The purpose of the research study is to collect blood samples and cerebrospinal fluid (CSF) from people with amyotrophic lateral sclerosis (ALS). These samples will be collected approximately every 4 months.

Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA

Biological samples will be collected from participants with ALS over time. These biological samples include blood (plasma, serum, and RNA) and cerebrospinal fluid (CSF). DNA will be collected at one time point.

Non-Probability Sample

Volunteers will be invited to participate in this study by their neurologists either in clinic or at a regular scheduled appointment visit

  • Amyotrophic Lateral Sclerosis
  • Nervous System Diseases
  • Sclerosis
  • Motor Neuron Disease
  • Spinal Cord Diseases
  • Central Nervous System Diseases
  • Neurodegenerative Diseases
  • Neuromuscular Diseases
  • ALS
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 or older
  • Diagnosis of suspected, possible, probable or definite ALS according to El Escorial Criteria
  • Vital capacity (VC) at least 50 percent predicted
  • Able to undergo multiple lumbar punctures

Exclusion Criteria:

  • Abnormal CSF pressure or intracranial/intraspinal tumors
  • Use of anticoagulant medication that cannot be safely withheld
  • Bleeding disorders

    • This is a partial listing.
18 Years and older
Contact: Daniela Grasso 617-726-0842 dgrasso@partners.org
United States
James D. Berry MD, Massachusetts General Hospital
Massachusetts General Hospital
  • ALS Association
  • ALS Finding a Cure
Principal Investigator: James D. Berry, MD, MPH Massachusetts General Hospital
Massachusetts General Hospital
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP