Multi-Center, Randomized Controlled Study of the NeuRx® Diaphragm Pacing System™ (DPS) In Participants with Amyotrophic Lateral Sclerosis (ALS)
Study Purpose:
The purpose of this study is to determine if surgical implantation of the NeuRx® Diaphragm Pacing System™ (DPS) improves survival or diaphragm function in individuals with ALS and breathing muscle weakness.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALSStudy Type:
Interventional TrialStudy Category:
DeviceStudy Status:
Not enrollingPhase:
Phase IIStudy Chair(s)/Principal Investigator(s):
Jeremy Shefner, MD (Barrow Neurological Institute)
Jonathan Katz, MD (California Pacific Medical Center)
Clinicaltrials.gov ID (11 digit #):
NCT01938495Neals Affiliated?
YesCoordinating Center Contact Information
Massachusetts General HospitalDaniela Grasso / .(JavaScript must be enabled to view this email address) / 617-726-0842
.(JavaScript must be enabled to view this email address) 165 Cambridge Street
Floor 6
Boston, Massachusetts 02114 United States
Full Study Summary:
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disorder affecting primarily motor neurons, for which treatment designed to slow or arrest progression remains lacking. As the disease progresses, breathing can become difficult due to weakening of the breathing muscles. The NeuRx® Diaphragm Pacing System™ (DPS) is a four channel, implanted percutaneous diaphragm muscle stimulation system, used to assist in diaphragm functioning. Since DPS has not been rigorously evaluated in ALS populations, a clinical trial has been designed to scientifically determine the effectiveness on improvement of diaphragm function and survival in ALS patients.
Approximately 180 eligible subjects with ALS will be recruited from multiple centers in the US. Subjects will be randomized 2:1 to receive the DPS implant or standard of care (control).
Study Sponsor:
Muscular Dystrophy Association (MDA), The ALS Association, and Synapse Biomedical, Inc.Participant Duration:
Subjects will take part in the study for approximately 18 months. Subjects will have 6 in-person visits and monthly phone visits during the study.