Recruiting

Observational Study

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT02374606

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

A 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 investigator will compare ATLIS data with data from the commonly used ALS outcomes measure, the ALS Functional Rating Scale-Revised (ALSFRS-R), as well as an exploratory measure, electrical impedance myography (EIM), in a prospective, longitudinal study. Both outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT02374606

Start date

Mar, 2015

Status verified date

Mar, 2018

Completion date

Feb, 2020

Anticipated

Primary completion date

Feb, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
  • Active movement of at least two limbs at the time of study entry
  • Intend to routinely attend clinic for neurological care at the clinical site

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).
  • Patients judged by the site clinical investigator to have significant clinical evidence of unstable medical or psychiatric illness will be excluded.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit [ Time Frame: every 1 to 4 months according to each patient's site visit schedule ]

Central Contacts and Locations

Central contacts

Ashley Fetterman

310-423-8497katherine.fetterman@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Ashley Fetterman

310-423-8497katherine.fetterman@CSHS.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Apr 3, 2018

Last verified

Mar, 2018

Keywords

  • outcomes measures
  • strength measurement
  • disease progression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2018-04-03.