This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS) (DPS in ALS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ALS Association
Muscular Dystrophy Association
Synapse Biomedical
Information provided by (Responsible Party):
Jeremy Shefner, Barrow Neurological Institute
ClinicalTrials.gov Identifier:
NCT01938495
First received: August 23, 2013
Last updated: December 22, 2016
Last verified: December 2016
  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.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis (ALS) Device: NeuRx® Diaphragm Pacing System™ (DPS) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Multi-Center, Randomized Controlled Study of the NeuRx® Diaphragm Pacing System™ (DPS)In Participants With Amyotrophic Lateral Sclerosis (ALS)

Resource links provided by NLM:


Further study details as provided by Jeremy Shefner, Barrow Neurological Institute:

Primary Outcome Measures:
  • Survival [ Time Frame: Subjects will be assessed on a monthly basis for an 18 month period. ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: Subjects will be assessed on a monthly basis for an 18 month period. ]

Enrollment: 52
Study Start Date: August 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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.
No Intervention: 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.

Detailed Description:

The study is a randomized controlled study to compare standard of care (control) to DPS (diaphragm stimulator named The NeuRx® Diaphragm Pacing System™). Although it remains uncertain if DPS is efficacious for the ALS subject, given the preliminary studies performed by the device manufacturer, it has received FDA humanitarian device exemption (HDE) approval as a humanitarian use device (HUD). This study will utilize a 2:1 randomization schedule such that eligible ALS subjects will have a 2/3 chance of receiving DPS and 1/3 chance of standard of care (control) treatment.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938495

  Show 25 Study Locations
Sponsors and Collaborators
Barrow Neurological Institute
ALS Association
Muscular Dystrophy Association
Synapse Biomedical
Investigators
Principal Investigator: Jeremy Shefner, MD, PhD Barrow Neurological Institute
Principal Investigator: Jonathan Katz, MD California Pacific Medical Center
  More Information

Additional Information:
Responsible Party: Jeremy Shefner, MD, PhD, Barrow Neurological Institute
ClinicalTrials.gov Identifier: NCT01938495     History of Changes
Other Study ID Numbers: 2013P001504
Study First Received: August 23, 2013
Last Updated: December 22, 2016

Keywords provided by Jeremy Shefner, Barrow Neurological Institute:
ALS
DPS
Diaphragm Pacing

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on June 23, 2017