Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT01938495
Last Updated: 2023-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2013-08-31
2017-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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NeuRx® Diaphragm Pacing System™ (DPS)
Patients randomized to the experimental arm will receive The NeuRx® Diaphragm Pacing System™ (DPS) device. Under general anesthesia, the intramuscular electrodes are surgically implanted in the diaphragm.
NeuRx® Diaphragm Pacing System™ (DPS)
The NeuRx® Diaphragm Pacing System™ (DPS) is a four channel, implanted percutaneous diaphragm muscle stimulation system. Pictures of the device are provided in the Clinician's Manual for the NeuRx® DPS procedure and technique guide from the manufacture Synapse Biomedical, Inc. 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.
Standard of Care
patients randomized to the standard of care arm will not have the Diaphragm Pacing System surgically implanted but will receive standard medical care.
No interventions assigned to this group
Interventions
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NeuRx® Diaphragm Pacing System™ (DPS)
The NeuRx® Diaphragm Pacing System™ (DPS) is a four channel, implanted percutaneous diaphragm muscle stimulation system. Pictures of the device are provided in the Clinician's Manual for the NeuRx® DPS procedure and technique guide from the manufacture Synapse Biomedical, Inc. 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.
Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
ALL
No
Sponsors
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ALS Association
OTHER
Muscular Dystrophy Association
OTHER
Synapse Biomedical
INDUSTRY
Barrow Neurological Institute
OTHER
Responsible Party
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Jeremy Shefner
MD, PhD
Principal Investigators
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Jeremy Shefner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Barrow Neurological Institute
Jonathan Katz, MD
Role: PRINCIPAL_INVESTIGATOR
California Pacific Medical Center
Locations
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Henry Ford Health Systems
Detroit, Michigan, United States
St Louis University
St 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
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
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
Countries
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Related Links
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Related Info
Other Identifiers
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2013P001504
Identifier Type: -
Identifier Source: org_study_id
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