Study Purpose:
The study is being conducted to determine if DPS treatment for people with ALS and hypoventilation is associated with improved survival or diaphragm function.The primary objective of the study is to conduct a multi-center, randomized controlled clinical trial comparing standard of care (control) to diaphragm stimulator treatment with the NeuRx® Diaphragm Pacing System™ (DPS) with respect to survival.
The secondary objective of the study is to conduct a multi-center, randomized controlled clinical trial to compare standard of care treatment (control) to DPS in ALS subjects with hypoventilation.
Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS)
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
NeuRx® Diaphragm Pacing System™ (DPS)
Placebo:
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Jeremy Shefner, MD, PhD, Barrow Neurological Institute, Jonathan Katz, MD, California Pacific Medical Center
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Massachusetts General Hospital
165 Cambridge Street
Boston, Massachusetts, 02114 United States
Full Study Summary:
The NeuRx® Diaphragm Pacing System™ (DPS) is a four channel, implanted percutaneous diaphragm muscle stimulation system. Under general anesthesia, the intramuscular electrodes are laparoscopically implanted in the diaphragm. The ends of the implanted electrodes are tunneled subcutaneously to an exit site on the chest or abdominal wall and connected to an external stimulator.
Study Sponsor:
Barrow Neurological Institute
Participant Duration:
Subjects will take part in the study for approximately 18 months. Subjects will have 6 in-person visits and monthly phone visits during the study.
Estimated Enrollment:
52
Estimated Study Start Date:
07 / 31 / 2013
Estimated Study Completion Date:
04 / 01 / 2017
Posting Last Modified Date:
03 / 09 / 2023
Date Study Added to neals.org:
09 / 10 / 2013
Minimum Age:
21 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
Inclusion Criteria:1. Age 21 years or older.
2. Sporadic or familial ALS diagnosed as definite, probable or possible ALS as defined by revised El Escorial criteria.
3. Evidence of hypoventilation at Screening with at least one of the following:
1. Maximal static inspiratory pressure (MIP) <60 cm H20.
2. Upright or supine forced vital capacity (FVC) <50% predicted for gender, age, and height.
4. A phrenic nerve potential should be recordable bilaterally.
5. Subjects must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to randomization (riluzole-naïve subjects are permitted in the study).
6. Capable of providing informed consent and following trial procedures.
7. Geographically accessible to the site.
8. Negative urine pregnancy test at Screening in women of child bearing potential (WOCBP). (Women who are post-menopausal or who have had a hysterectomy are deemed not of child bearing potential).
9. Women of child bearing potential must use an adequate form of contraception: abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception or other hormonal (patch or contraceptive ring, for example) contraception), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method.
Exclusion Criteria:
1. Upright forced vital capacity (FVC) ≤ 45% of predicted for gender, age, and height.
2. Any prior use of non-invasive ventilation (NIV) outside of sleep (nighttime or naps).
3. Any pulmonary or cardiac disorder or other medical disorder that would be a contraindication for general anesthesia or DPS hardware implantation in the chest.
4. Implanted electrical device such as a pacemaker or cardiac defibrillator.
5. Known diaphragm abnormality such as hiatal hernia or para-esophageal hernia of abdominal contents into the thoracic cavity.
6. Participation in another treatment research study for people with ALS.
7. Exposure to any other agent currently under investigation for the treatment of people with ALS (off-label use or investigational) within 30 days of the Screening Visit.
8. Clinically significant history of unstable or severe cardiac, oncologic, hepatic, psychiatric, renal disease, or other medically significant illness.
9. Pregnant women or women currently breastfeeding.
Barrow Neurological Institute
Phoenix, Arizona
United States
Cedars-Sinai Medical Center
Los Angeles, California
United States
California Pacific Medical Center
San Diego, California
United States
Stanford University
Stanford, California
United States
Hospital for Special Care
New Britain, Connecticut
United States
Mayo Clinic Florida
Jacksonville, Florida
United States
University of Florida, Jacksonville
Jacksonville, Florida
United States
University of Iowa
Iowa City, Iowa
United States
Massachusetts General Hospital
Boston, Massachusetts
United States
Henry Ford Health Systems
Detroit, Michigan
United States
St Louis University
Saint Louis, Missouri
United States
Neurology Associates P.C.
Lincoln, Nebraska
United States
Hospital for Special Surgery
New York, New York
United States
SUNY Upstate Medical University
Syracuse, New York
United States
Carolinas Health Care
Charlotte, North Carolina
United States
Wake Forest University
Winston-Salem, North Carolina
United States
Cleveland Clinic
Cleveland, Ohio
United States
Ohio State University
Columbus, Ohio
United States
Providence ALS Center
Portland, Oregon
United States
Drexel University
Philadelphia, Pennsylvania
United States
University of Pittsburgh
Pittsburgh, Pennsylvania
United States
University of Texas Southwestern
Dallas, Texas
United States
University of Texas
San Antonio, Texas
United States
University of Vermont
Burlington, Vermont
United States
Virginia Mason Medical Center
Seattle, Washington
United States