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

Trial ID or NCT#

NCT01938495

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Multi-Center, Randomized Controlled Study of the NeuRx® Diaphragm Pacing System™ (DPS)In Participants With Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

Investigator(s)

Sarada Sakamuri, MD
Sarada Sakamuri, MD
Neuromuscular neurologist, General neurologist, Neurophysiologist, Neurologist
Clinical Associate Professor, Adult Neurology Clinical Associate Professor (By courtesy), Neurosurgery

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Contact

Shirley Paulose
650-724-3792