Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)

PHASE2CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

January 31, 2017

Study Completion Date

April 30, 2017

Conditions
Amyotrophic Lateral Sclerosis (ALS)
Interventions
DEVICE

NeuRx® Diaphragm Pacing System™ (DPS)

The NeuRx® Diaphragm Pacing System™ (DPS) is a four channel, implanted percutaneous diaphragm muscle stimulation system. Pictures of the device are provided in the Clinician's Manual for the NeuRx® DPS procedure and technique guide from the manufacture Synapse Biomedical, Inc. Under general anesthesia, the intramuscular electrodes are laparoscopically implanted in the diaphragm. The ends of the implanted electrodes are tunneled subcutaneously to an exit site on the chest or abdominal wall and connected to an external stimulator.

Trial Locations (25)

Unknown

Barrow Neurological Institute, Phoenix

Cedars-Sinai Medical Center, Los Angeles

California Pacific Medical Center, San Diego

Stanford University, Stanford

Hospital for Special Care, New Britain

Mayo Clinic Florida, Jacksonville

University of Florida, Jacksonville, Jacksonville

University of Iowa, Iowa City

Massachusetts General Hospital, Boston

Henry Ford Health Systems, Detroit

St Louis University, St Louis

Neurology Associates P.C., Lincoln

Hospital for Special Surgery, New York

SUNY Upstate Medical University, Syracuse

Carolinas Health Care, Charlotte

Wake Forest University, Winston-Salem

Cleveland Clinic, Cleveland

Ohio State University, Columbus

Providence ALS Center, Portland

Drexel University, Philadelphia

University of Pittsburgh, Pittsburgh

University of Texas Southwestern, Dallas

University of Texas, San Antonio

University of Vermont, Burlington

Virginia Mason Medical Center, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ALS Association

OTHER

collaborator

Muscular Dystrophy Association

OTHER

collaborator

Synapse Biomedical

INDUSTRY

lead

Barrow Neurological Institute

OTHER

NCT01938495 - Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS) | Biotech Hunter | Biotech Hunter