Multi-Center, Randomized Controlled Study of the NeuRx® Diaphragm Pacing System™ (DPS) In Participants with Amyotrophic Lateral Sclerosis (ALS)

Full Study Summary:

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder affecting primarily motor neurons, for which treatment designed to slow or arrest progression remains lacking. As the disease progresses, breathing can become difficult due to weakening of the breathing muscles. The NeuRx® Diaphragm Pacing System™ (DPS) is a four channel, implanted percutaneous diaphragm muscle stimulation system, used to assist in diaphragm functioning. Since DPS has not been rigorously evaluated in ALS populations, a clinical trial has been designed to scientifically determine the effectiveness on improvement of diaphragm function and survival in ALS patients.

Approximately 180 eligible subjects with ALS will be recruited from multiple centers in the US. Subjects will be randomized 2:1 to receive the DPS implant or standard of care (control).

• Eligibility Criteria

  Gender:

  Female, Male

  Minimum Age:

  21

  Maximum Age:

  N/A

  Min Vital Capacity (% predicted normal):

  50

  Time since Symptom Onset:

  N/A

  Time since Diagnosis:

  N/A

  Can participants use Riluzole?

  Yes

  
  

  Study subjects meeting all of the following criteria will be allowed to enroll in the study:
  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:
  a. Maximal static inspiratory pressure (MIP) <60 cm H20
  b. Upright or supine forced vital capacity (FVC) <50% predicted for gender, age, and height
  4. Both hemi-diaphragms must be able to be stimulated with standard phrenic nerve conduction studies
  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
  Study subjects meeting any of the following criteria during screening evaluations will be excluded from entry into the study:
  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 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.

• Site Contact Information

  Barrow Neurological Institute
  Gale Kittle / .(JavaScript must be enabled to view this email address) / Phoenix, Arizona 85013
  United States

  Cedars-Sinai Medical Center
  Ashley Fetterman / .(JavaScript must be enabled to view this email address) / Los Angeles, California 90048
  United States

  California Pacific Medical Center
  Marguerite Engel / .(JavaScript must be enabled to view this email address) / 415-309-5178
  San Diego, California 94114
  United States

  Stanford University
  Shirley Paulose / .(JavaScript must be enabled to view this email address) / 650-724-3792
  Stanford, California 94305
  United States

  Hospital for Special Care
  Boguslawa (Agnes) Koczon-Jaremko; Nicole Allard / .(JavaScript must be enabled to view this email address) / 860-612-6356; 860-612-6356
  New Britain, Connecticut 06053
  United States

  Mayo Clinic Florida
  Pamela DeSaro / .(JavaScript must be enabled to view this email address) / 904-953-6915
  Jacksonville, Florida 32224
  United States

  University of Florida, Jacksonville
  Lisa Smith / .(JavaScript must be enabled to view this email address) / Jacksonville, Florida 32209
  United States

  University of Iowa
  Jeri Sieren / .(JavaScript must be enabled to view this email address) / 319-356-8744
  Des Moines, Iowa 52242
  United States

  Massachusetts General Hospital
  Fernando Gonterman / .(JavaScript must be enabled to view this email address) / 617-726-0563
  Boston, Massachusetts 02114
  United States

  Henry Ford Health Systems
  Beverly Stallings / .(JavaScript must be enabled to view this email address) / 313-916-3955
  Detroit, Michigan 48202
  United States

  St. Louis University
  Craig Dedert / .(JavaScript must be enabled to view this email address) / 314-577-8461
  St. Louis, Missouri 63103
  United States

  Neurology Associates P.C.
  Rebecca Wills / .(JavaScript must be enabled to view this email address) / 402-413-3187
  Lincoln, Nebraska 68510
  United States

  Hospital for Special Surgery
  Lindsay Kaplan / .(JavaScript must be enabled to view this email address) / 646-797-8657
  New York, New York 10021
  United States

  SUNY Upstate Medical University
  Andrea McGlond / .(JavaScript must be enabled to view this email address) / 315-464-6409
  Syracuse, New York 13210
  United States

  Carolinas Health Care
  Cynthia Larry / .(JavaScript must be enabled to view this email address) / 704-446-1987
  Charlotte, North Carolina 28203
  United States

  Wake Forest University
  Mozhdeh Marandi / .(JavaScript must be enabled to view this email address) / 336-713-8577
  Winston-Salem, North Carolina 27106
  United States

  Cleveland Clinic
  Irys Caristo / .(JavaScript must be enabled to view this email address) / Cleveland, Ohio 44195
  United States

  Ohio State University
  Colleen Pineda / .(JavaScript must be enabled to view this email address) / 614-685-5661
  Columbus, Ohio 43210
  United States

  Providence ALS Center
  Chad Parks / .(JavaScript must be enabled to view this email address) / 503-962-1171
  Portland, Oregon 97213
  United States

  Drexel University
  Christine Barr / .(JavaScript must be enabled to view this email address) / 267-507-2633
  Philadelphia, Pennsylvania 19104
  United States

  University of Pittsburgh
  Danielle Rowlands / .(JavaScript must be enabled to view this email address) / 412-648-9053
  Pittsburgh, Pennsylvania 15260
  United States

  University of Texas Southwestern
  Nina Gorham / .(JavaScript must be enabled to view this email address) / 214-648-9518
  Dallas, Texas 75390
  United States

  University of Texas
  Pamela Kittrell / .(JavaScript must be enabled to view this email address) / 210-450-0524
  San Antonio, Texas 78705
  United States

  University of Vermont
  Shannon Lucy / .(JavaScript must be enabled to view this email address) / 802-656-4582
  Burlington, Vermont 05405
  United States

  Virginia Mason Medical Center
  Leslie Stevens / .(JavaScript must be enabled to view this email address) / 206-342-6929
  Seattle, Washington 98101
  United States

• Study Results

  This study has suspended participant recruitment.