Trial ID or NCT#

NCT01605006

Status

RECRUITING

Purpose

This post-approval study will follow 60 participants who have ALS, documented chronic hypoventilation, and bilateral phrenic nerve function, and who undergo the surgical implantation procedure to receive the NeuRx Diaphragm Pacing System device. Participants who are successfully implanted with the device will use it for daily diaphragm conditioning sessions. Participants will be followed for at least two years (until the last enrolled participant reaches the 2-year follow-up visit). Safety and probable benefit outcome measures will be assessed.

Official Title

HDE Post-Approval Study (PAS) of NeuRx DPS for ALS

Eligibility Criteria

Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Yuen So, MD, PhD
Neuromuscular neurologist, Neurophysiologist
Professor of Neurology at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Shirley Paulose
650-724-3792