Clinical Trial Details

NCT ID: NCT01605006
Date Last Changed: May 30, 2014


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


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.

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Recruitment Details

Both Male and Female
21 and up
Overall Status
Lead Sponsor
Synapse Biomedical
62 Months
Facility Type


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

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.

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

Teerin Liewluck, MD
Principal Investigator
United States Florida Jacksonville 32224 Mayo Clinic
Pamela DeSaro

Kevin Boylan, MD
Principal Investigator
United States Illinois Chicago 60611 Northwestern University
Helen Donnelly

Lisa Wolfe, MD
Principal Investigator
United States Kansas Kansas City 66160 University of Kansas Medical Center
Maureen Walsh

April McVey, MD
Principal Investigator
United States Nebraska Omaha 68198 University of Nebraska Medical Center
Elspeth McKeon

Jose Americo Fernandes Filho, MD
Principal Investigator
United States New York Stony Brook 11794 Stony Brook University
Jessica Lamb

Nurcan Gursoy, MD
Principal Investigator
United States North Carolina Durham 27705 Duke University
Karen Grace

Richard Bedlack, MD
Principal Investigator
United States Ohio Cleveland 44106 University Hospitals Case Medical Center
Mary Jo Elmo

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

Kimberly Goslin, MD
Principal Investigator


Michael Fritz
888-767-3770 ext. 134

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