Humanitarian Device Exemption Post-Approval Study of NeuRx Diaphragm Pacing System for Amyotrophic Lateral Sclerosis



Status:Active, not recruiting
Conditions:Neurology, ALS
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:21 - Any
Updated:4/21/2016
Start Date:July 2012
End Date:September 2017

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HDE Post-Approval Study (PAS) of NeuRx DPS for ALS

This post-approval study will follow 60 participants who have ALS, documented chronic
hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical
implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who
are successfully implanted with the device will use it for daily diaphragm conditioning
sessions. Participants will be followed for at least two years (until the last enrolled
participant reaches the 2-year follow-up visit). Safety and probable benefit outcome
measures will be assessed.

This is a prospective, non-randomized, open-label, interventional, post-approval (FDA) study
of the NeuRx Diaphragm Pacing System (DPS) device. The study will enroll 60 participants who
have amyotrophic lateral sclerosis (ALS), meet the FDA-approved device indications for use,
and undergo the surgical implantation procedure to receive the device. The device is
intended for use in ALS patients with a stimulatable diaphragm (both right and left
portions) as demonstrated by voluntary contraction or phrenic nerve conduction studies, and
who are experiencing chronic hypoventilation (CH), but not progressed to an FVC less than
45% predicted. Participants who are successfully implanted with the device will use it for
daily diaphragm conditioning sessions. Participants will be followed for at least two years
(until the last enrolled participant reaches the 2-year follow-up visit). Safety and
probable benefit outcome measures will be assessed. The primary objective of the study is:
(1) (Safety) Characterize the types and frequency of major device-related adverse events
(AEs) over the time of device use. Secondary objectives of the study are: (2) (Safety)
Determine whether the frequency of major device-related AEs increases dramatically toward
end of life; and (3) (Probable Benefit) Determine whether there is a relationship between
survival time and onset type (bulbar and limb), time from onset to treatment, and use of
NIV, riluzole, or PEG in patients treated with the device.

Inclusion Criteria:

1. Age 21 or older.

2. Participants with familial or sporadic ALS diagnosed as laboratory-supported
probable, probable, or definite according to the World Federation of Neurology El
Escorial criteria.

3. Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral
diaphragm movement with fluoroscopic sniff test or with EMG recordings and nerve
conduction times.

4. 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

5. Suitable surgical candidate.

6. Negative pregnancy test in female participants of childbearing potential.

7. Informed consent from patient or designated representative.

Exclusion Criteria:

1. Underlying cardiac or pulmonary disease that would increase the risk of general
anesthesia.

2. Underlying pulmonary diseases that were present prior to ALS that would affect
pulmonary tests independent of ALS.

3. Uncontrolled excessive secretions.

4. FVC less than 45% predicted at time of surgery.

5. Preexisting implanted electrical device such as pacemaker or cardiac defibrillator.

6. Pre-existing diaphragm abnormality such as a hiatal hernia or paraesophageal hernia
of abdominal contents going into the thoracic cavity.
We found this trial at
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Denver, Colorado 80291
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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303 East Superior Street
Chicago, Illinois 60611
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Cleveland, OH
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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9205 SW Barnes Rd
Portland, Oregon 97225
(503) 216-1234
Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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Stony Brook, New York 11794
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