Longitudinal Study of Outcomes Measures in ALS Trials

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Longitudinal Study Comparing the Responsiveness of Outcomes Measures in ALS Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911130
• Other study ID #: 2013P000702
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: March 22, 2017
• Start date: July 2013
• Est. completion date: March 2016

Study information

• Verified date: September 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	University of Kentucky	Lexington	Kentucky
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Washington University	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	ALS Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Accurate Test of Limb Isometric Strength (ATLIS) between each visit	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.	every 1 to 4 months for up to two years
Secondary	Change in ALS Functional Rating Scale - Revised (ALSFRS-R) between each visit	This questionnaire consists of 12 questions about the subject's ability to function in certain daily activities. Questions are asked in an interview format.	every 1 to 4 months for up to 2 years
Secondary	Change in Slow Vital Capacity (SVC) between each visit	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.	Every 1 to 4 months for up to two years