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Completed

NCT Number: NCT01911130

Longitudinal Study of Outcomes Measures in ALS Trials

A new strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure static limb strength in patients with ALS. The investigators will compare ATLIS data with data from two commonly used ALS outcomes measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC) in a prospective, longitudinal study. All three outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Disease Attributes Disease Progression Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

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About this study

Four sites will participate in data collection for this study and will enroll approximately 20-30 subjects per site. Subjects will be tested every 1 to 4 months for up to two years. Subjects will be tested at each visit using ATLIS, ALSFRS-R questionnaire and slow vital capacity testing.

Inclusion criteria

  • Subjects 18 years or older diagnosed with clinically possible, laboratory supported probable, probable or clinically definite ALS according to the World Federation of Neurology Revised El Escorial Criteria.
  • Capable of providing informed consent and complying with trial procedures.

Exclusion criteria

  • Patients, judged by the site clinical investigator to have medical conditions that may limit their ability to safely exert maximal force using the muscles in their arms and legs will be excluded from this study (e.g. unstable hypertension, significant cardiac disease, significant musculoskeletal disorders, or other medical conditions).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • clinically possible, laboartory supported probable, probable or clinically definite ALS according to El Escorial Criteria
  • capable of providing informed consent

Exclusion criteria

  • persons with medical conditions that would limit their ability to safely exert maximal force using muscles in their arms and legs (e.g. unstable cardiac, musculoskeletal, or other medical conditions)

Treatment and study plan

Primary outcomes

  1. Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit

    Time frame: every 1 to 4 months for up to two years

    ATLIS measures isometric strength in 12 muscle groups in the arms and legs. The subject is tested seated in a specially designed chairs with adjustable uprights. The subject's limb is placed in a standard position and maximal force is exerted on the wireless load cell fixed to the upright. Strength data is digitally captured and expressed as a percentage of expected normal.

Secondary outcomes

  1. Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit

    Time frame: every 1 to 4 months for up to 2 years

    This questionnaire consists of 12 questions about the subject's ability to function in certain daily activities. Questions are asked in an interview format.

  2. Change in Slow Vital Capacity (SVC) between each visit

    Time frame: Every 1 to 4 months for up to two years

    SVC measures the amount of air you can exhale following a deep breath. For this test, we will ask you to hold a mouthpiece in your mouth, breathe in deeply, and breathe out as much air as you can, up to 5 times.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • ALS Association

Registry information

Official study title

Longitudinal Study Comparing the Responsiveness of Outcomes Measures in ALS Trials

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 30, 2013
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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