Home » Clinical Trials » Amyotrophic Lateral Sclerosis (ALS)
Clinical Trial Details
Research Study Summary
A clinical research study of NeuRx Diaphragm Pacing System (DPS) for the treatment of Amyotrophic Lateral Sclerosis (ALS)
Research Study Title
HDE Post-Approval Study (PAS) of NeuRx DPS for ALS
This post-approval study will follow 60 participants who have ALS, documented chronic
hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical
implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants
who are successfully implanted with the device will use it for daily diaphragm conditioning
sessions. Participants will be followed for at least two years (until the last enrolled
participant reaches the 2-year follow-up visit). Safety and probable benefit outcome
measures will be assessed.
To Learn more
Both Male and Female
Both Male and Female ages 21 Years and up
Age 21 or older.
Participants with familial or sporadic ALS diagnosed as laboratory-supported
probable, probable, or definite according to the World Federation of Neurology El
Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral
diaphragm movement with fluoroscopic sniff test or with EMG recordings and nerve
Chronic hypoventilation was documented by at least one of the following:
FVC less than 50% predicted, or
|MIP| less than 60 cmH2O, or
PaCO2 greater than or equal to 45 mmHg, or
Nocturnal SaO2 less than or equal to 88% for at least five continuous minutes
Suitable surgical candidate.
Negative pregnancy test in female participants of childbearing potential.
Informed consent from patient or designated representative.
Underlying cardiac or pulmonary disease that would increase the risk of general
Underlying pulmonary diseases that were present prior to ALS that would affect
pulmonary tests independent of ALS.
Uncontrolled excessive secretions.
FVC less than 45% predicted at time of surgery.
Preexisting implanted electrical device such as pacemaker or cardiac defibrillator.
Pre-existing diaphragm abnormality such as a hiatal hernia or paraesophageal hernia
of abdominal contents going into the thoracic cavity.
Site Locations (11)
||Cedars-Sinai Medical Center
Robert Baloh, MD
||California Pacific Medical Center -- Forbes Norris MDA/ALS Research Center
Robert G. Miller, M.D.
Robert G. Miller, M.D.
||University of Colorado Denver
Alexander (AJ) Stein
Teerin Liewluck, MD
Kevin Boylan, MD
Lisa Wolfe, MD
||University of Kansas Medical Center
April McVey, MD
||University of Nebraska Medical Center
Jose Americo Fernandes Filho, MD
||Stony Brook University
Nurcan Gursoy, MD
Richard Bedlack, MD
||University Hospitals Case Medical Center
Mary Jo Elmo
Mary Jo Elmo, CNP
||Providence St. Vincent Medical Center
Kimberly Goslin, MD
NCT ID: NCT01605006
Date Last Changed: May 30, 2014
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