Deep Phenotyping in Patients With ALS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02819765|
Recruitment Status : Unknown
Verified January 2019 by Barrow Neurological Institute.
Recruitment status was: Recruiting
First Posted : June 30, 2016
Last Update Posted : January 8, 2019
|Condition or disease|
|ALS Motor Neuron Disease|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Fluid Biomarkers With Deep Phenotyping in Patients With ALS|
|Actual Study Start Date :||February 7, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
- ALS Functional Rating Scale Revised (ALSFRS-R) [ Time Frame: Every 6 months through month 18 ]The ALSFRS-R is a quickly administered (5 minutes) instrument used to determine subjects' assessment of their capability and independence in 12 functional activities, each rated on an ordinal scale (ratings 0-4).
- Slow vital capacity (SVC) [ Time Frame: Every 6 months through month 18 ]Vital capacity will be measured as slow vital capacity (SVC) using standard technique
- Hand held dynamometry (HHD) [ Time Frame: Every 6 months through month 18 ]Hand held dynamometry (HHD) will be used as a quantitative measure of muscle strength for this study. 10 muscle groups will be examined bilaterally in both upper and lower extremities. Mean and standard deviation for each muscle group will be established from the initial values for each subject in this trial, so that strength determinations can be converted to Z scores and averaged to provide an HHD megascore for both upper and lower extremities.
- ALS cognitive behavioral screen (ALS-CBS) [ Time Frame: Every 6 months through month 18 ]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.
- Multipoint incremental motor unit number estimates (MIMUNE) [ Time Frame: Every 6 months through month 18 ]MIMUNE is a validated technique to estimate the number of motor units in specific muscles of patients. In this study it will be performed on one intrinsic hand muscle unilaterally throughout the study.
- Paired Pulse Stimulation Using Transcranial Magnetic Stimulation (TMS) [ Time Frame: Every 6 months through month 18 ]TMS is a technique that uses a focused magnetic field to depolarize neurons of interest. By depolarizing motor neurons and measuring the evoked response, an assessment of the neuronal excitability can be determined.
- Threshold tracking nerve conduction studies (ttNCS) [ Time Frame: Every 6 months through month 18 ]ttNCS is a technique that uses stimulation of peripheral motor nerves to measure a variety of variables to determine the excitability of the peripheral motor neurons.
- MRI Cytography [ Time Frame: At baseline and at 6 months ]The MRI scan is a non-invasive procedure that uses a powerful magnetic field and radio waves to obtain images of internal organs and tissues.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819765
|Contact: Kerisa Shelton, PhD||602-406-6598||Kerisa.Shelton@DignityHealth.org|
|Contact: Meghan Hall||Meghan.Hall@DignityHealth.org|
|United States, Arizona|
|Barrow Neurological Institute||Recruiting|
|Phoenix, Arizona, United States, 85013|
|Contact: Nicole Turcotte, MPH 602-406-4775 firstname.lastname@example.org|
|Principal Investigator: Shafeeq S Ladha, MD|
|United States, California|
|University of California, Irvine, Dept. of Neurology||Recruiting|
|Orange, California, United States, 92868|
|Contact: Ivonne M Turner 714-456-8323 email@example.com|
|Principal Investigator: Namita Goyal, MD|
|Sub-Investigator: Tahseen Mozaffar, MD|
|Sub-Investigator: Tim Lai, MD|
|Sub-Investigator: Monica Lavian, DO|
|United States, Michigan|
|University of Michigan | Neurology - ALS Clinic||Suspended|
|Ann Arbor, Michigan, United States, 48109|
|Grand Rapids, Michigan, United States, 49503|
|Contact: Brandon James 616-486-2058 Brandon.James@spectrumhealth.org|
|Principal Investigator: Paul T Twydell, DO|
|United States, New York|
|Hospital for Special Surgery (HSS)||Recruiting|
|New York, New York, United States, 10021|
|Contact: Mona Shahbazi 212-774-2361|
|Principal Investigator: Dale Lange, MD|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Diana Dimitrova, PhD 503-494-7269 firstname.lastname@example.org|
|Principal Investigator: Chafic Karam, MD|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19122|
|Contact: Kathleen Hatala, RN, BSN 215-707-4171 email@example.com|
|Principal Investigator: Terry Heiman-Patterson, MD|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Danielle Rowlands 412-864-2873 firstname.lastname@example.org|
|Principal Investigator: David Lacomis, MD|
|United States, South Carolina|
|Department of Neurosurgery & Neurology | Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Michelle DeCandio, RN, OCN 843-792-9016 email@example.com|
|Contact: Katrina Madden 843-792-9186 firstname.lastname@example.org|
|Principal Investigator: I-Hweii Amy Chen, MD, PhD|
|Principal Investigator:||Shafeeq Ladha, MD||Barrow Neurological Institute|