New ALS Study; Accepting new enrollments starting in January 2017.
Please check the Synapse Biomedical site for updates on participating centers.
A multi-center, concurrent-controlled, on-label study of the NeuRx® Diaphragm Pacing System (DPS) participants with Amyotrophic Lateral Sclerosis (ALS) on non-invasive ventilation.
|Intended Use:||The NeuRx® Diaphragm Pacing System (DPS) is a percutaneous, intramuscular, diaphragm motor point stimulating device intended for use in amyotrophic lateral sclerosis (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. For use only in patients 21 years of age or older.|
|Study Purpose:||Characterize the safety and benefit of on-label Humanitarian Device Exemption (HDE) use of DPS in patients with ALS who initiated noninvasive ventilation (NIV).|
|1. Compare the survival of patients who initiated noninvasive ventilation (NIV) and who receive DPS to controls on non-invasive ventilation: (1) concurrent controls; (2) historical controls (e.g., Lechtzin and PRO-ACT databases); and (3) virtual controls (Origent).
2. Determine whether there is a relationship between survival time and clinical features including: onset type (bulbar and limb); time from onset of weakness from ALS to treatment; UMN/LMN assessment scores; use of DPS, NIV, riluzole, or PEG; and intraoperative strength of contraction.
3. Characterize longitudinal change in overall function (ALSFRS-R) and respiratory function (FVC, MIP) before and after treatment with DPS compared to controls.
4. Characterize the types and frequency of device- and procedure-related adverse events (AEs) occurring in patients who receive the DPS device.
5. Compare the types and frequency of respiratory serious adverse events in patients who receive DPS to concurrent controls.
|Participating Sites:||4 – 20 sites|
|Planned Number of Subjects:||54 subjects receiving DPS
54 control subjects not receiving DPS
|Study Population:||Inclusion Criteria:
1. Age 21 or older
2. Familial or sporadic ALS diagnosed as possible, 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 phrenic nerve conduction studies
4. Chronic hypoventilation was documented by at least one of the following:
5. Initiation of non-invasive ventilation at or before time of enrollment
6. Suitable surgical candidate to receive diaphragm pacing stimulation
7. Negative pregnancy test in female participants of childbearing potential (treatment group)
8. Informed consent from patient or designated representative
1. FVC less than 45% predicted within 10 days prior to surgery
2. Participation in simultaneous therapeutic clinical trial which could affect the safety or benefit outcomes of this study