A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers
|ClinicalTrials.gov Identifier: NCT01495390|
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : May 30, 2017
|Condition or disease|
|Amyotrophic Lateral Sclerosis Nervous System Diseases Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases ALS|
|Study Type :||Observational|
|Actual Enrollment :||139 participants|
|Official Title:||A Multicenter Study for the Discovery and Validation of ALS Biomarkers|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
- ALS Functional Rating Scale [ Time Frame: Approximately every 4 months ]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 ]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 ]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 ]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 ]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 ]
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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495390
|United States, Arizona|
|Barrow Neurological Institute|
|Phoenix, Arizona, United States, 85013|
|United States, Florida|
|Mayo Clinic Jacksonville|
|Jacksonville, Florida, United States, 32224|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|University of Massachusetts Medical Center|
|Worcester, Massachusetts, United States, 01655|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||James D. Berry, MD, MPH||Massachusetts General Hospital|