Overview

This trial is active, not recruiting.

Condition amyotrophic lateral sclerosis (als)
Treatment neurx diaphragm pacing system (dps)
Sponsor Synapse Biomedical
Start date July 2012
End date September 2017
Trial size 97 participants
Trial identifier NCT01605006, CLIN 20-0009-0020

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
All study participants who meet the study eligibility criteria will undergo the surgical implantation procedure to receive the NeuRx DPS. Participants who are successfully implanted with the electrodes will use the NeuRx DPS system for diaphragm conditioning.
neurx diaphragm pacing system (dps) diaphragm pacing
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Probable Benefit Outcome Measure
time frame: follow-up assessments at 3-month intervals

Eligibility Criteria

Male or female participants at least 21 years old.

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.

Additional Information

Official title HDE Post-Approval Study (PAS) of NeuRx DPS for ALS
Principal investigator Robert G. Miller, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Synapse Biomedical.