Clinical trial NCT03034317: NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS)
Official title: Multi-Center, Concurrent-Controlled, On-Label Study of the NeuRx Diaphragm Pacing System (DPS) in Participants With Amyotrophic Lateral Sclerosis (ALS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Diaphragm Pacing
Lead sponsor: Synapse Biomedical
Sponsor class: INDUSTRY
First posted: 2017-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients.

Detailed description: Characterize the safety and benefit of on-label Humanitarian Device Exemption (HDE) use of DPS in patients with ALS who initiated noninvasive ventilation (NIV).

Eligibility criteria: Inclusion Criteria:

* Age 21 or older
* Familial or sporadic ALS diagnosed as possible, 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 phrenic nerve conduction studies
* Chronic hypoventilation was documented by at least one of the following:

  * MIP (respiratory muscle strength) less than 60 cmH2O, or
  * Forced Vital Capacity (FVC) less than 50% predicted, or
  * PaCO2 greater than or equal to 45 mmHg, or
  * Nocturnal SaO2 (arterial oxygen saturation) less than or equal to 88% for at least five continuous minutes
* Initiation of non-invasive ventilation at or before time of enrollment
* Suitable surgical candidate to receive diaphragm pacing stimulation
* Negative pregnancy test in female participants of childbearing potential (treatment group)
* Informed consent from patient or designated representative

Exclusion Criteria:

* FVC less than 45% predicted within 10 days prior to surgery.
* Participation in simultaneous therapeutic clinical trial which could affect the safety or benefit outcomes of this study.

Primary outcomes:
measure: Survival
timeFrame: 24 months
Secondary outcomes:
measure: Relationship between survival time and clinical features of ALS
timeFrame: 24 months
measure: Relationship between survival time and ALS assessment scores
timeFrame: 24 months
measure: Relationship between survival time and onset of weakness from ALS to treatment
timeFrame: 24 months
measure: Relationship between survival time and ALS treatment interventions
timeFrame: 24 months
measure: Relationship between survival time and intraoperative strength of contraction
timeFrame: 24 months
measure: Characterize change in overall and respiratory function
timeFrame: 24 months
measure: Characterize change in respiratory function
timeFrame: 24 months
measure: Types device and procedure-related adverse events
timeFrame: 24 months
measure: Frequency of device and procedure-related adverse events
timeFrame: 24 months
measure: Types of respiratory serious adverse events
timeFrame: 24 months
measure: Frequency of respiratory adverse events
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: California Pacific Medical Center
name: Robert Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: