Skip Navigation

Advertise|Press|Contact|FAQ|About Us

Bookmark/Print/Share

Home » Clinical Trials » Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Details

Overview

Research Study Summary

A clinical research study of NeuRx Diaphragm Pacing System (DPS) for the treatment of Amyotrophic Lateral Sclerosis (ALS)

Research Study Title

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

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.

To Learn more
Gender

Both Male and Female

Age

21 and up

Overall Status

Recruiting

Lead Sponsor

Synapse Biomedical

Duration

62 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 21 Years and up

Inclusion Criteria:

  1. Age 21 or older.

  2. Participants with familial or sporadic ALS diagnosed as laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria.

  3. Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with EMG recordings and nerve conduction times.

  4. Chronic hypoventilation was documented by at least one of the following:

  5. FVC less than 50% predicted, or

  6. |MIP| less than 60 cmH2O, or

  7. PaCO2 greater than or equal to 45 mmHg, or

  8. Nocturnal SaO2 less than or equal to 88% for at least five continuous minutes

  9. Suitable surgical candidate.

  10. Negative pregnancy test in female participants of childbearing potential.

  11. Informed consent from patient or designated representative.

Exclusion Criteria:

  1. Underlying cardiac or pulmonary disease that would increase the risk of general anesthesia.

  2. Underlying pulmonary diseases that were present prior to ALS that would affect pulmonary tests independent of ALS.

  3. Uncontrolled excessive secretions.

  4. FVC less than 45% predicted at time of surgery.

  5. Preexisting implanted electrical device such as pacemaker or cardiac defibrillator.

  6. Pre-existing diaphragm abnormality such as a hiatal hernia or paraesophageal hernia of abdominal contents going into the thoracic cavity.

Site Locations (11)

Country State City Zip Facility and Contact
United States California Los Angeles 90048 Cedars-Sinai Medical Center
Tami Kendra-Romito
tami.kendra@cshs.org

Robert Baloh, MD
Principal Investigator
United States California San Francisco 94115 California Pacific Medical Center -- Forbes Norris MDA/ALS Research Center
Robert G. Miller, M.D.
415-600-3604
MillerRX@cpmcri.org

Robert G. Miller, M.D.
Principal Investigator
United States Colorado Denver 80045 University of Colorado Denver
Alexander (AJ) Stein
alexander.stein@ucdenver.edu

Teerin Liewluck, MD
Principal Investigator
United States Florida Jacksonville 32224 Mayo Clinic
Pamela DeSaro
desaro.pamela@mayo.edu

Kevin Boylan, MD
Principal Investigator
United States Illinois Chicago 60611 Northwestern University
Helen Donnelly
h-donnelly@northwestern.edu

Lisa Wolfe, MD
Principal Investigator
United States Kansas Kansas City 66160 University of Kansas Medical Center
Maureen Walsh
mwalsh@kumc.edu

April McVey, MD
Principal Investigator
United States Nebraska Omaha 68198 University of Nebraska Medical Center
Elspeth McKeon
emckeon@nebraskamed.com

Jose Americo Fernandes Filho, MD
Principal Investigator
United States New York Stony Brook 11794 Stony Brook University
Jessica Lamb
jessica.lamb@stonybrookmedicine.edu

Nurcan Gursoy, MD
Principal Investigator
United States North Carolina Durham 27705 Duke University
Karen Grace
karen.grace@duke.edu

Richard Bedlack, MD
Principal Investigator
United States Ohio Cleveland 44106 University Hospitals Case Medical Center
Mary Jo Elmo
maryjo.elmo@uhhospitals.org

Mary Jo Elmo, CNP
Principal Investigator
United States Oregon Portland 97213 Providence St. Vincent Medical Center
Nancy Hoke
nancy.hoke@providence.org

Kimberly Goslin, MD
Principal Investigator

Contact

Michael Fritz
888-767-3770 ext. 134
E-mail:

NCT ID: NCT01605006

Date Last Changed: May 30, 2014

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials. Some study summaries have been edited for clarity purposes to make them easier to understand. View more study details here.