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

NCT01938495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-03-09

No results posted yet for this study

Summary

The study is being conducted to determine if DPS treatment for people with ALS and hypoventilation is associated with improved survival or diaphragm function.

The primary objective of the study is to conduct a multi-center, randomized controlled clinical trial comparing standard of care (control) to diaphragm stimulator treatment with the NeuRx® Diaphragm Pacing System™ (DPS) with respect to survival.

The secondary objective of the study is to conduct a multi-center, randomized controlled clinical trial to compare standard of care treatment (control) to DPS in ALS subjects with hypoventilation.

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.

Sponsors & Collaborators

  • ALS Association

    collaborator OTHER

  • Muscular Dystrophy Association

    collaborator OTHER

  • Synapse Biomedical

    collaborator INDUSTRY

  • Barrow Neurological Institute

    lead OTHER

Principal Investigators

  • Jeremy Shefner, MD, PhD · Barrow Neurological Institute

  • Jonathan Katz, MD · California Pacific Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-01-31
Completion
2017-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01938495 on ClinicalTrials.gov