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Trial record 6 of 519 for:    ALS (Amyotrophic Lateral Sclerosis)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01938495
Recruitment Status : Unknown
Verified December 2016 by Jeremy Shefner, Barrow Neurological Institute.
Recruitment status was:  Active, not recruiting
First Posted : September 10, 2013
Last Update Posted : December 23, 2016
Sponsor:
Collaborators:
ALS Association
Muscular Dystrophy Association
Synapse Biomedical
Information provided by (Responsible Party):
Jeremy Shefner, Barrow Neurological Institute

Tracking Information
First Submitted Date  ICMJE August 23, 2013
First Posted Date  ICMJE September 10, 2013
Last Update Posted Date December 23, 2016
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
Survival [ Time Frame: Subjects will be assessed on a monthly basis for an 18 month period. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01938495 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2013)
quality of life [ Time Frame: Subjects will be assessed on a monthly basis for an 18 month period. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE Multi-Center, Randomized Controlled Study of the NeuRx® Diaphragm Pacing System™ (DPS)In Participants With Amyotrophic Lateral Sclerosis (ALS)
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: NeuRx® Diaphragm Pacing System™ (DPS)
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 22, 2016)
52
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2013)
180
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01938495
Other Study ID Numbers  ICMJE 2013P001504
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeremy Shefner, Barrow Neurological Institute
Study Sponsor  ICMJE Barrow Neurological Institute
Collaborators  ICMJE
  • ALS Association
  • Muscular Dystrophy Association
  • Synapse Biomedical
Investigators  ICMJE
Principal Investigator: Jeremy Shefner, MD, PhD Barrow Neurological Institute
Principal Investigator: Jonathan Katz, MD California Pacific Medical Center
PRS Account Barrow Neurological Institute
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP