NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS) (PARADIGM)

Synapse Biomedical

Status

Withdrawn

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Device: NeuRx DPS

Study type

Interventional

Funder types

Industry

Identifiers

NCT03034317

20-1000-51

Details and patient eligibility

About

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

Full 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).

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.