Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis
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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: NCT01605006 |
Recruitment Status :
Completed
First Posted : May 24, 2012
Last Update Posted : March 27, 2020
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Condition or disease | Intervention/treatment | Phase |
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Amyotrophic Lateral Sclerosis (ALS) | Device: NeuRx Diaphragm Pacing System (DPS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 97 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | HDE Post-Approval Study (PAS) of NeuRx DPS for ALS |
Actual Study Start Date : | July 2012 |
Actual Primary Completion Date : | February 2017 |
Actual Study Completion Date : | February 2017 |

Arm | Intervention/treatment |
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NeuRx Diaphragm Pacing System (DPS)
Surgical implantation of the NeuRx DPS (on label use).
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Device: NeuRx Diaphragm Pacing System (DPS)
The NeuRx DPS is a percutaneous, intramuscular, diaphragm stimulation system which is implanted using standard laparoscopic surgical techniques in an outpatient procedure. The implanted intramuscular diaphragm electrodes are connected to a four channel external stimulator at a percutaneous exit site. DPS is designed to help ALS patients breathe by providing conditioning stimulation of the diaphragm muscles. Recommended frequency of diaphragm conditioning is at least 3 times per day with each session lasting at least 30 minutes. Patients may find it helpful to use the DPS for longer periods to help with breathing. DPS may be used at the same time as non-invasive ventilation. Patents may also sleep with the DPS to assist with breathing difficulties at night.
Other Names:
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- Safety Outcome Measure -- Occurrence of major device-related (including procedure-related) adverse events as defined below. [ Time Frame: follow-up assessments at 3-month intervals ]
- Serious capnothorax requiring invasive intervention
- Mechanical ventilation for 24 hours or longer post-procedure
- Post-procedure extubation failure resulting in permanent tracheostomy ventilation
- Perioperative complication which delays initiation of NeuRx DPS therapy
- Severe discomfort due to stimulation which is unable to be tolerated or resolved
- Device malfunction which interrupts or causes an undesired diminution of NeuRx DPS therapy
- Electrode dislodgement from the diaphragm
- Wire infection
- Any other device- or procedure-related serious adverse event
- Probable Benefit Outcome Measure [ Time Frame: follow-up assessments at 3-month intervals ]Survival, defined as time to (a) death or (b) permanent tracheostomy mechanical ventilation (PTV) with discontinuation of pacing. (All deaths and PTV events will be reported regardless of relationship to the device or procedure.)

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 21 or older.
- Participants with familial or sporadic ALS diagnosed as laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria.
- Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with EMG recordings and nerve conduction times.
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Chronic hypoventilation was documented by at least one of the following:
- FVC less than 50% predicted, or
- |MIP| less than 60 cmH2O, or
- PaCO2 greater than or equal to 45 mmHg, or
- Nocturnal SaO2 less than or equal to 88% for at least five continuous minutes
- Suitable surgical candidate.
- Negative pregnancy test in female participants of childbearing potential.
- Informed consent from patient or designated representative.
Exclusion Criteria:
- Underlying cardiac or pulmonary disease that would increase the risk of general anesthesia.
- Underlying pulmonary diseases that were present prior to ALS that would affect pulmonary tests independent of ALS.
- Uncontrolled excessive secretions.
- FVC less than 45% predicted at time of surgery.
- Preexisting implanted electrical device such as pacemaker or cardiac defibrillator.
- Pre-existing diaphragm abnormality such as a hiatal hernia or paraesophageal hernia of abdominal contents going into the thoracic cavity.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01605006
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
California Pacific Medical Center -- Forbes Norris MDA/ALS Research Center | |
San Francisco, California, United States, 94115 | |
United States, Colorado | |
University of Colorado Denver | |
Denver, Colorado, United States, 80045 | |
United States, Florida | |
Mayo Clinic | |
Jacksonville, Florida, United States, 32224 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 | |
United States, New York | |
Stony Brook University | |
Stony Brook, New York, United States, 11794 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
University Hospitals Case Medical Center | |
Cleveland, Ohio, United States, 44106 | |
United States, Oregon | |
Providence St. Vincent Medical Center | |
Portland, Oregon, United States, 97213 |
Principal Investigator: | Robert G. Miller, M.D. | Forbes Norris MDA/ALS Research Center, California Pacific Medical Center |
Responsible Party: | Synapse Biomedical |
ClinicalTrials.gov Identifier: | NCT01605006 |
Other Study ID Numbers: |
CLIN 20-0009-0020 |
First Posted: | May 24, 2012 Key Record Dates |
Last Update Posted: | March 27, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
amyotrophic lateral sclerosis ALS motor neuron disease diaphragm diaphragm pacing diaphragmatic pacing phrenic pacing phrenic nerve phrenic nerve stimulation |
NeuRx DPS DPS chronic hypoventilation respiration ventilation breathing Humanitarian Device Exemption HDE post-approval study |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |